Endoscopic device with helical lumen design

ABSTRACT

An endolumenal robotic system provides the surgeon with the ability to drive a robotically-driven endoscopic device to a desired anatomical position in a patient without the need for awkward motions and positions, while also enjoying improved image quality from a digital camera mounted on the endoscopic device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/523,760 (Attorney Docket No. 41663-712.201), filed Oct. 24, 2014,which claims priority to U.S. Provisional Patent Application No.61/895,312, (Attorney Docket No. 41663-711.101), filed Oct. 24, 2013;U.S. Provisional Patent Application No. 61/895,315, (Attorney Docket No.41663-712.101), filed Oct. 24, 2013; U.S. Provisional Patent ApplicationNo. 61/895,602, (Attorney Docket No. 41663-713.101), filed Oct. 25,2013; U.S. Provisional Patent Application No. 61/940,180, (AttorneyDocket No. 41663-714.101), filed Feb. 14, 2014; U.S. Provisional PatentApplication No. 62/019,816, (Attorney Docket No. 41663-713.102), filedJul. 1, 2014; and U.S. Provisional Patent Application No. 62/037,520,(Attorney Docket No. 41663-715.101), filed Aug. 14, 2014; the entirecontents of which are incorporated herein by reference.

This application is filed on the same day as and claims a common chainof priority as the following applications: U.S. patent application Ser.No. ______ (Attorney Docket No. 41663-712.302); U.S. patent applicationSer. No. ______ (Attorney Docket No. 41663-712.303); and U.S. patentapplication Ser. No. ______ (Attorney Docket No. 41663-712.304).

BACKGROUND OF THE INVENTION 1. Field of the Invention

The field of the present application pertains to medical devices. Moreparticularly, the field of the invention pertains to systems and toolsfor robotic-assisted endolumenal surgery.

2. Description of the Related Art

Endoscopy is a widely-used, minimally invasive technique for bothimaging and delivering therapeutics to anatomical locations within thehuman body. Typically a flexible endoscope is used to deliver tools toan operative site inside the body—e.g., through small incisions or anatural orifice in the body (nasal, anal, vaginal, urinary, throat,etc.)—where a procedure is performed. Endoscopes may have imaging,lighting and steering capabilities at the distal end of a flexible shaftenabling navigation of non-linear lumens or pathways.

To assist with the navigation, the endoscopes often have a means toarticulate a small distal bending section. Today's endoscopic devicesare typically hand held devices with numerous levers, dials, and buttonsfor various functionalities, but offer limited performance in terms ofarticulation. For control, physicians control the position and progressof the endoscope by manipulating the leavers or dials in concert withtwisting the shaft of the scope. These techniques require the physicianto contort their hands and arms when using the device to deliver thescope to the desired position. The resulting arm motions and positionsare awkward for physicians; maintaining those positions can also bephysically taxing. Thus, manual actuation of bending sections is oftenconstrained by low actuation force and poor ergonomics.

There are additional challenges with today's endoscopic devices. Today'sendoscopes typically require support personnel to both deliver, operateand remove operative, diagnostic or therapeutic devices from the scopewhile the physician maintains the desired position. Today's endoscopesutilize pull wires that create issues with curve alignment and muscling.Some procedures require fluoroscopy or segmented CT scans to assist innavigating to the desired location, particularly for small lumennavigation.

Therefore, it would be beneficial to have a system and tools forendolumenal procedures that provide improved ergonomics, usability, andnavigation.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides for a system performingrobotically-assisted surgical procedures that comprises a first roboticarm with a proximal end and a distal section, a first mechanism changerinterface coupled to the distal section of the first robotic arm, afirst instrument device manipulator coupled to the first mechanismchanger interface, the first instrument device manipulator beingconfigured to operate robotically-driven tools that are configured toperform surgical procedures at an operative site in a patient, andwherein the first instrument device manipulator comprises a drive unit.

In related devices, the drive unit comprises a motor. In someembodiments, the first instrument device manipulator is configured to bereleasably disengaged from the mechanism changer interface and the firstrobotic arm.

In related devices, the first mechanism changer interface is configuredto interface with a plurality of instrument device manipulators. In someembodiments, first mechanism changer interface is configured to conveyelectrical signals from the first robotic arm to the first instrumentdevice manipulator.

In related devices, the present invention further comprises anendoscopic tool coupled to the first instrument device manipulator, theendoscopic tool comprising a primary elongated body. In someembodiments, an electromagnetic tracker is coupled to the distal sectionof the primary elongated body. In some embodiments, an accelerometer iscoupled to the distal section of the primary elongated body.

In related devices, the primary elongated body comprises a workingchannel longitudinally aligned with a neutral axis of the primaryelongated body, and a pull lumen aligned at an angle in a helix aroundthe working channel. In some embodiments, the angle of the helix variesalong the length of the primary elongated body. In some embodiments, thepull lumen contains an elongated tendon fixedly coupled to the distalsection of the primary elongated body and responsive to the firstinstrument device manipulator.

In related devices, the endoscopic tool further comprises a secondaryelongated body that is longitudinally aligned around the primaryelongated body, wherein the primary elongated body comprises a proximalsection and a distal section, and wherein a digital camera is coupled tothe distal end. In some embodiments, the system further comprises asecond robotic arm coupled to a second instrument device manipulatorthrough a second mechanism changer interface, wherein the secondinstrument device manipulator is coupled to the endoscopic tool, and thefirst instrument device manipulator and the second instrument devicemanipulator are configured to align to form a virtual rail to operatethe endoscopic tool. In some embodiments, the first instrument devicemanipulator operatively controls the secondary elongated body and thesecond instrument device manipulator operatively controls the primaryelongated body. In some embodiments, the first robotic arm and thesecond robotic arm are coupled to a movable system cart. In someembodiments, the first robotic arm and the second robotic arm arecoupled to an operating bed that is configured to hold the patient. Insome embodiments, the system cart is configured to send sensor data to acommand console and receive command signals from the command console. Insome embodiments, the command console is separate from the system cart.In some embodiments, the command console comprises a display module anda control module for controlling the endoscopic tool. In someembodiments, the control module is a joystick controller.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described, by way of example, and with referenceto the accompanying diagrammatic drawings, in which:

FIG. 1 illustrates a robotic endoscopic system, in accordance with anembodiment of the present invention;

FIG. 2A illustrates a robotic surgery system in accordance with anembodiment of the present invention;

FIG. 2B illustrates an overhead view of system 200 where anesthesia cart201 is provided towards the head of the patient;

FIG. 2C shows an a view of system 200 in FIG. 2A;

FIGS. 2D and 2E illustrate alternative arrangements of arms 202 and 204showing the versatility of the robotic surgical system in accordancewith embodiments of the present invention;

FIG. 3A illustrates an overhead view of a system with multiple virtualrails, in accordance with an embodiment of the present invention;

FIG. 3B illustrates the use of robotic surgery system from FIG. 3A withan additional robotic arm, associated tool base, and tool;

FIG. 4 illustrates a robotic surgery system with interchangeable IDMsand tools, in accordance with an embodiment of the present invention;

FIG. 5A illustrates an implementation of a mechanism changer interfacecoupled to a robotic arm in a robotic system, in accordance with anembodiment of the present invention;

FIG. 5B illustrates an alternative view of male mechanism changerinterface 502 from FIG. 5A;

FIG. 5C illustrates a reciprocal female mechanism changer interfacecoupled to an instrument device manipulator for connecting with malemechanism changer interface 502 from FIGS. 5A and 5B;

FIG. 5D illustrates an alternative view of female mechanism changerinterface 508 from FIG. 5C;

FIG. 6 illustrates a robotic surgery system that uses a single portlaparoscopic instrument connected through an instrument interface on asingle robotic arm that is directed at the abdomen of a patient, inaccordance with an embodiment of the present invention;

FIG. 7 illustrates a robotic surgery system with two sets of roboticsubsystems, each with a pair of arms, in accordance with an embodimentof the present invention;

FIG. 8A illustrates a robotic surgery system with a subsystem with asingle robotic arm, where a microscope tool is connected to the roboticarm through an instrument interface, in accordance with an embodiment ofthe present invention;

FIG. 8B illustrates a robotic surgery system where subsystem 801 fromFIG. 8A may be used in conjunction with another subsystem to performmicrosurgery, in accordance with an embodiment of the present invention;

FIG. 9A illustrates a portion of a robotic medical system that includesa manipulator, in accordance with an embodiment of the presentinvention;

FIG. 9B illustrates an alternative view of the robotic medical systemdisclosed in FIG. 9A;

FIG. 10 illustrates an alternative view of the independent drivemechanism from FIGS. 9A, 9B with a tension sensing apparatus inaccordance with an embodiment of the present invention;

FIG. 11A illustrates a cutaway view of the independent drive mechanismfrom FIGS. 9A, 9B, and 10 from an alternate angle;

FIG. 11B illustrates a cutaway view of the previously discussedindependent drive mechanism in combination with an endoscopic tool, inaccordance with an embodiment of the present invention;

FIG. 12 illustrates an alternative view of the previously-discussedindependent drive mechanism with pull wires from an endoscopic tool inaccordance with an embodiment of the present invention;

FIG. 13 illustrates a conceptual diagram that shows how horizontalforces may be measured by a strain gauge oriented perpendicular to theforces, in accordance with an embodiment of the invention;

FIG. 14 is an illustration of an endoscopic tool that may be used inconjunction with a robotic system 100 from FIG. 1, in accordance with anembodiment of the present invention;

FIGS. 15A, 15B, 15C, 16A, and 16B generally illustrate aspects of arobotically-driven endoscopic tool, in accordance with an embodiment ofthe present invention;

FIGS. 17A to 17D illustrates how prior art flexible instruments exhibitundesirable “muscling” phenomenon when tendons are pulled;

FIGS. 17E to 17H illustrate how prior art flexible instruments sufferfrom curve alignment phenomenon during use in non-linear pathways;

FIGS. 171 and 17J illustrate how the muscling and curve alignmentphenomena is substantially resolved through the provision of a helixedsection, in accordance with an embodiment of the present invention;

FIG. 18 illustrates the structure of a flexible endoscopic tool with anaxially stiff tube within a lumen, in accordance with an embodiment ofthe present invention;

FIG. 19 illustrates the structure of a helical pattern within a lumen ofa flexible endoscopic tool, in accordance with an embodiment of thepresent invention;

FIG. 20A illustrates an endoscopic tool from a robotic endolumenalsystem, in accordance with an embodiment of the present invention;

FIG. 20B illustrates an alternative view of endoscopic tool 2000 fromFIG. 20A;

FIG. 21 illustrates the distal end of an endoscopic tool, in accordancewith an embodiment of the present invention;

FIG. 22 illustrates a flowchart for a method of constructing anendoscopic device with helical lumens, in accordance with an embodimentof the present invention;

FIG. 23 illustrates a system for manufacturing a flexible endoscope, inaccordance with an embodiment of the present invention;

FIG. 24 illustrates a specialized nose cone for manufacturing anendoscopic device with helical pull lumens, in accordance with anembodiment of the present invention;

FIGS. 25A and 25B illustrates the relationship between centerlinecoordinates, diameter measurements and anatomical spaces;

FIG. 26 illustrates a computer-generated three-dimensional modelrepresenting an anatomical space, in accordance with an embodiment ofthe invention;

FIG. 27 illustrates a robotic endolumenal system that makes use of anelectromagnetic tracker in combination with an electromagnetic fieldgenerator, in accordance with an embodiment in the present invention;

FIG. 28 illustrates a flow diagram for the steps for registration, inaccordance with an embodiment of the present invention;

FIG. 29A illustrates the distal end of an endoscopic tool within ananatomical lumen, in accordance with an embodiment of the presentinvention;

FIG. 29B illustrates the endoscopic tool from FIG. 29A in use at anoperative site within an anatomical lumen, in accordance with anembodiment of the present invention;

FIG. 29C illustrates the endoscopic tool from FIG. 29B in use at anoperative site within an anatomical lumen, in accordance with anembodiment of the present invention;

FIG. 30A illustrates an endoscopic tool coupled to a distal flexuresection within an anatomical lumen, in accordance with an embodiment ofthe present invention;

FIG. 30B illustrates an endoscopic tool from FIG. 30A with a forcepstool in use at an operative site within an anatomical lumen, inaccordance with an embodiment of the present invention;

FIG. 30C illustrates an endoscopic tool from FIG. 30A with a laserdevice in use at an operative site within an anatomical lumen, inaccordance with an embodiment of the present invention; and

FIG. 31 illustrates a command console for a robotic endolumenal system,in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Although certain preferred embodiments and examples are disclosed below,inventive subject matter extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses, and tomodifications and equivalents thereof. Thus, the scope of the claimsappended hereto is not limited by any of the particular embodimentsdescribed below. For example, in any method or process disclosed herein,the acts or operations of the method or process may be performed in anysuitable sequence and are not necessarily limited to any particulardisclosed sequence. Various operations may be described as multiplediscrete operations in turn, in a manner that may be helpful inunderstanding certain embodiments; however, the order of descriptionshould not be construed to imply that these operations are orderdependent. Additionally, the structures, systems, and/or devicesdescribed herein may be embodied as integrated components or as separatecomponents.

For purposes of comparing various embodiments, certain aspects andadvantages of these embodiments are described. Not necessarily all suchaspects or advantages are achieved by any particular embodiment. Thus,for example, various embodiments may be carried out in a manner thatachieves or optimizes one advantage or group of advantages as taughtherein without necessarily achieving other aspects or advantages as mayalso be taught or suggested herein.

1. Overview.

An endolumenal surgical robotic system provides the surgeon with theability to sit down in an ergonomic position and control a roboticendoscopic tool to the desired anatomical location within a patientwithout the need for awkward arm motions and positions.

The robotic endoscopic tool has the ability to navigate lumens withinthe human body with ease by providing multiple degrees of freedom atleast two points along its length. The tool's control points provide thesurgeon with significantly more instinctive control of the device as itnavigates a tortuous path within the human body. The tip of the tool isalso capable of articulation from zero to ninety degrees for all threehundred and sixty degrees of roll angles.

The surgical robotic system may incorporate both external sensor-basedand internal vision-based navigation technologies in order to assist thephysician with guidance to the desired anatomical location within thepatient. The navigational information may be conveyed in eithertwo-dimensional display means or three-dimensional display means.

2. System Components.

FIG. 1 is a robotic endoscopic system, in accordance with an embodimentof the present invention. As shown in FIG. 1, robotic system 100 maycomprises a system cart 101 with at least one mechanical arm, such asarm 102. The system cart 101 may be in communication with aremotely-located command console (not shown). In practice, the systemcart 101 may be arranged to provide access to a patient, while aphysician may control the system 100 from the comfort of the commandconsole. In some embodiments, the system cart 100 may be integrated intothe operating table or bed for stability and access to the patient.

Within system 100, arm 102 may be fixedly coupled to a system cart 101that contains a variety of support systems, including controlelectronics, power sources and optical sources in some embodiments. Thearm 102 may be formed from a plurality of linkages 110 and joints 111 toenable access to the patient's operative region. The system cart 103 maycontain source of power 112, pneumatic pressure 113, and control andsensor electronics 114—including components such as central processingunit, data bus, control circuitry, and memory—and related actuators ormotors that may drive arms such as arm 102. Power may be conveyed fromthe system cart 101 to the arm 102 using a variety of means known to oneskilled in the art such as electrical wiring, gear heads, air chambers.The electronics 114 in system cart 101 may also process and transmitcontrol signals communicated from a command console.

The system cart 101 may also be mobile, as shown by the wheels 115. Insome embodiments, the system cart may capable of being wheeled to thedesired location near the patient. System cart(s) 101 may be located invarious locations in the operating room in order to accommodate spaceneeds and facilitate appropriate placement and motion of modules andinstruments with respect to a patient. This capability enables the armsto be positioned in locations where they do not interfere with thepatient, doctor, anesthesiologist or any supportive surgical equipmentrequired for the selected procedure. During procedures, the arms withinstruments will work collaboratively via user control through separatecontrol devices, which may include a command console with hapticdevices, joystick, or customized pendants.

3. Mechanical Arms.

The proximal end of arm 102 may be fixedly mounted or coupled to thecart 101. Mechanical arm 102 comprises a plurality of linkages 110,connected by at least one joint per arm, such as joints 111. Ifmechanical arm 102 is robotic, joints 111 may comprise one or moreactuators in order to affect movement in at least one degree of freedom.The arm 102, as a whole, preferably has more than three degrees offreedom. Through a combination of wires and circuits, each arm may alsoconvey both power and control signals from system cart 101 to theinstruments located at the end of their extremities.

In some embodiments, the arms may be fixedly coupled to the operatingtable with the patient. In some embodiments, the arms may be coupled tothe base of the operating table and reach around to access patient.

In some embodiments, the mechanical arms may not be robotically-driven.In those embodiments, the mechanical arms are comprised of linkages andset up joints that use a combination of brakes and counter-balances tohold the position of the arms in place. In some embodiments,counter-balances may be constructed from gas springs or coil springs.Brakes, such as fail safe brakes, may be mechanical orelectro-mechanical. In some embodiments, the arms may begravity-assisted passive support arms.

Distally, each arm may be coupled to a removable Instrument DeviceManipulator (IDM), such as 117, through a Mechanism Changer Interface(MCI), such as 116. In the preferred embodiment, the MCI 116 may containconnectors to pass pneumatic pressure, electrical power, electricalsignals, and optical signals from the arm to the IDM 117. In someembodiments, MCI 116 may be as simple as a set screw or base plateconnection.

IDM 117 may have a variety of means for manipulating a surgicalinstrument including, direct drive, harmonic drive, geared drives, beltsand pulleys, or magnetic drives. One skilled in the art would appreciatethat a variety of methods may be used control actuators on instrumentdevices.

Within the robotic system, the MCIs, such as 116, may be interchangeablewith a variety of procedure-specific IDMs, such as 117. In thisembodiment, the interchangeability of the IDMs allow robotic system 100to perform different procedures.

Preferred embodiments may use a robotic arm with joint level torquesensing having a wrist at the distal end, such as Kuka AG's LBR5. Theseembodiments have a robotic arm with seven joints, with redundant jointsprovided to avoid potential arm collision with a patient, other robotarms, operating table, medical personal or equipment proximate to theoperative field, while maintaining the wrist at the same pose so as notto interrupt an ongoing procedure. The skilled artisan will appreciatethat a robotic arm with at least three degrees of freedom, and morepreferably six or more degrees of freedom, will fall within theinventive concepts described herein, and further appreciate that morethan one arm may be provided with additional modules, where each arm maybe commonly or separately mounted on one or more carts.

4. Virtual Rail Configuration.

Arm 102 in system 100 may be arranged in a variety of postures for usein a variety of procedures. For example, in combination with anotherrobotic system, the arm 102 of system 100 may be arranged to align itsIDM to form a “virtual rail” that facilitates the insertion andmanipulation of an endoscopic tool 118. For other procedures, the armsmay be arranged differently. Thus, the use of arms in system 100provides flexibility not found in robotic systems whose design isdirectly tied to specific medical procedure. The arms of system 100provides potentially much greater stroke and stowage.

FIG. 2A illustrates a robotic surgery system 200 in accordance with anembodiment of the present invention. System 200 has first arm 202 andsecond arm 204 holding endoscopic tool bases 206 and 208, respectively.Tool base 206 has controllable endoscope sheath 210 operativelyconnected thereto. Tool base 208 has flexible endoscope leader 212operatively connected thereto.

Arms 202 and 204 align tool bases 206 and 208 such that proximal end 216of sheath 210 is distal of the proximal end 222 of leader 212, and suchthat leader 212 remains axially aligned with sheath 210 at anapproximate angle of 180 degrees between the two arms, resulting in a“virtual rail” where the rail is approximately straight, or at 180degrees. As will be described later, the virtual rail may have anglesbetween 90-180 degrees. In one embodiment, sheath 210, with leader 212slidingly disposed therethrough, is robotically inserted through, forexample, a tracheal tube (not shown) in the mouth of and into patient211, and ultimately into the patient's bronchial system, whilecontinually maintaining the virtual rail during insertion andnavigation. The arms may move sheath 210 and endoscope 212 axiallyrelative to each other and in to or out of patient 211 under the controlof a doctor (not shown) at a control console 203 (from FIG. 2B).

Navigation is achieved, for example, by advancing sheath 210 along withleader 212 into the patient 211, then leader 212 may be advanced beyonddistal end 213 of the sheath, and the sheath 210 may then be broughteven with the leader 212, until a desired destination is reached. Othermodes of navigation may be used, such as and not by way of limitationusing a guide wire through the working channel of the leader 212. Thephysician may be using any number of visual guidance modalities orcombination thereof to aid navigation and performing the medicalprocedure, e.g., fluoroscopy, video, CT, MR etc. Distal end 220 ofleader 212 may then be navigated to an operative site and tools aredeployed through a longitudinally-aligned working channel within leader212 to perform desired procedures. The virtual rail may be maintainedduring the navigation procedure and any subsequent operative procedures.Any number of alternative procedures that may require a tool or no toolat all can be performed using the flexible endoscope sliding through thesheath, as the skilled artisan will appreciate.

FIG. 2B illustrates an overhead view of system 200 where anesthesia cart201 is provided towards the head of the patient. Additionally, controlconsole 203 with a user interface is provided to control sheath 210,endoscope leader 212, and the associated arms 202 and 204 and tool bases206 and 208 (see FIG. 2A).

FIG. 2C shows an angled view of system 200 in FIG. 2A. Tool modules 206and 208 with associated sheath 210 and leader 212 are attached to arms202 and 204 and arranged in a 180 degree virtual rail. The arms areshown on a single cart, which provides added compactness and mobility.As will be discussed later, tool bases 206 and 208 have pulley systemsor other actuation systems to tension tendons in sheath 210 and leader212 to steer their respective distal ends. Tool bases 206 and 208 mayprovide other desired utilities for the sheath and endoscope, such aspneumatic pressure, electrical, data communication (e.g., for vision),mechanical actuation (e.g., motor driven axels) and the like. Theseutilities may be provided to the tool bases through the arms, from aseparate source or a combination of both.

FIGS. 2D and 2E illustrate alternative arrangements of arms 202 and 204showing the versatility of the robotic surgical system in accordancewith embodiments of the present invention. In FIG. 2D, arms 202 and 204may be extended to position the instrument (comprising sheath 210 andleader 212) to enter the mouth of patient 211 at 75 degrees fromhorizontal, while still maintaining a 180 degree virtual rail. This maybe done during the procedure if required to accommodate spacerequirements within the room. The 75 degree angle was chosen fordemonstrative purposes, not by way of limitation.

FIG. 2E shows an alternative arrangement of arms 202 and 204 where thetool bases 206 and 208 are aligned to create a virtual rail with a 90degree angle, in accordance with an embodiment of the present invention.In this embodiment, the instrument (comprising sheath 210 and leader212) enters the mouth of patient 213 at 75 degrees from horizontal. Toolbases 206 and 208 are aligned such that the leader 212 bends 90 degreesat tool base 206 prior to entering the mouth of patient 213. Tofacilitate the bend of leader 212, a rigid or semi-rigid structure, suchas a tube, may be used to ensure smooth extension and retraction of theleader 212 within sheath 210. Extension and retraction of leader 212within sheath 210 may be controlled by moving tool base 208 eithercloser or farther from tool base 206 along the linear path tracked byleader 212. Extension and retraction of sheath 210 may be controlled bymoving tool base 206 closer or farther from patient 213 along the linearpath tracked by sheath 210. To avoid unintended extension or retractionof leader 212 while extending or retracting sheath 210, tool base 208may also be moved along a linear path parallel to sheath 210.

Virtual rails are useful in driving both rigid instrument and flexibleinstruments, and especially where there are telescoping requirements.The use of a virtual rail is not limited to a single rail but canconsist of multiple virtual rails where the arms act in concert tomaintain the individual virtual rails in performance of one or moreprocedures.

FIG. 3A illustrates an overhead view of a system with multiple virtualrails, in accordance with an embodiment of the present invention. InFIG. 3A, robot arms 302, 304 and 306 respectively hold tool bases 308,310, and 312. Tool bases 308 and 310 may be operatively coupled toflexible tool 314 and tool 316. Tool 314 and tool 316 may be atelerobotically-controlled flexible endoscopic instruments. Tool base312 may be operatively coupled to a dual lumen sheath 318, where eachlumen receives tools 314 and 316. Arms 302 and 304 may each maintain avirtual rail with robotic arm 306, and movements of all three arms maybe coordinated to maintain virtual rails and move tools 314, 316 andsheath 318 relative to each other and the patient.

FIG. 3B illustrates the use of the robotic surgery system from FIG. 3Awith an additional robotic arm 320 and associated tool base 322 and tool324. In this embodiment sheath 325 may have three lumens. Alternatively,sheath 325 may comprise more than one sheath to provide access to tools314, 316, and 324. As will be appreciated, the ability to increase orreduce the number of arms with associated modules and instrumentspermits a great number and flexibility of surgical configurations,which, in turn, permits re-purposing of expensive arms and use ofmultiple relatively-inexpensive modules to achieve great versatility atreduced expense.

Thus, to create the virtual rail, a plurality of arms and/or platformsmay be utilized. Each platform/arm must be registered to the others,which can be achieved by a plurality of modalities including, vision,laser, mechanical, magnetic, or rigid attachment. In one embodiment,registration may be achieved by a multi-armed device with a single baseusing mechanical registration. In mechanical registration, an embodimentmay register arm/platform placement, position, and orientation based ontheir position, orientation and placement relative to the single base.In another embodiment, registration may be achieved by a system withmultiple base using individual base registration and “hand-shaking”between multiple robot arms. In embodiments with multiple bases,registration may be achieved by touching together arms from differentbases, and calculating locations, orientation and placement based on (i)the physical contact and (ii) the relative locations of those bases. Insome embodiments, registration targets may be used to match the positionand orientations of the arms relative to each other. Through suchregistration, the arms and instrument driving mechanisms may becalculated in space relative to each other.

5. Mechanism Changer Interface.

Returning to FIG. 1, robotic surgical system 100 may be configured in amanner to provide a plurality of surgical system configurations, such asby changing IDM 117 and tool 118 (also known as an end effector). Thesystem may comprise one or more mobile robotic platforms staged atdifferent locations in the operative room, or at a convenient nearbylocation. Each platform may provide some or all of power, pneumaticpressure, illumination sources, data communication cables and controlelectronics for a robotic arm that is coupled to the platform, and themodule may draw from these utilities as well. System 100 mayalternatively have multiple arms 102 mounted on one or more mobile carts101, or the arms may be mounted to the floor in order to provide aplurality of surgical configurations.

In addition to multiple arms and platforms, some embodiments aredesigned to readily exchange between multiple modules or end effectormechanisms. Various surgical procedures or steps within a procedure mayrequire the use of different modules and the associated instrument sets,for example, exchanging between different sized sheath and endoscopecombinations. Interchangeability allows the system to reconfigure fordifferent clinical procedures or adjustments to surgical approaches.

FIG. 4 illustrates a robotic surgery system with interchangeable IDMsand tools, in accordance with an embodiment of the present invention.Surgical system 400 has a mechanical arm 401 to which IDM 402 and tool403 are attached. Attached to system cart 404, IDMs 405 and 406, andassociated tools 407 and 408 may be exchanged onto robotic arm 401 orpicked up by a different robotic arm (not shown) to be used alone inconcert with another IDM and tool. Each IDM may be a dedicatedelectromechanical system which may be used to drive various types ofinstruments and tools for specified procedures. To drive instruments,each IDM may comprise an independent drive system, which may include amotor. They may contain sensors (e.g., RFID) or memory chips that recordtheir calibration and application related information. A systemcalibration check may be required after a new mechanism is connected tothe robot arm. In some embodiments, an IDM may control an endoscopicsheath or flexible endoscopic leader.

In FIG. 4, system 400 may exchange IDM 402 for IDMs 405 and 406 byitself through the use of global registration and sensors. In someembodiments, IDMs 406 and 408 are stored on system cart 404 atpredetermined “docking stations” which are configured withidentification and proximity sensors. Sensors at these stations may makeuse of technologies such as RFID, optical scanners (e.g., bar codes),EEPROMs, and physical proximity sensors to register and identify whichIDMs are “docked” at the docking station. As robotic arm 401 and the IDMdocking stations reside on system cart 404, the identification andproximity sensors allow the IDMs that are resting in the dockingstations to be registered relative to the robotic arm(s). Similarly, inembodiments with multiple arms on a single system cart, multiple armsmay access the IDMs on the docking station using the combination ofregistration system and sensors discussed above.

FIG. 5 illustrates a mechanism changer interface in a robotic system, inaccordance with an embodiment of the present invention. FIG. 5Aspecifically illustrates an implementation of a mechanism changerinterface coupled to a robotic arm in a robotic system, in accordancewith an embodiment of the present invention. As shown in FIG. 5A, thedistal portion of robotic arm 500 comprises an articulating joint 501coupled to a “male” mechanism changer interface 502. Articulating joint501 provides an additional degree of freedom with respect tomanipulating an instrument device mechanism (not shown) that isconfigured to couple to robotic arm 500. Male mechanism changerinterface 502 provides a male connector interface 503 that provides astrong, physical connection to the reciprocal female receptacleconnector interface on the IDM (not shown). The spherical indentationson the male connector interface 503 physically couple to reciprocalindentations on the female receptacle interface on the IDM. Thespherical indentations may be extended when pneumatic pressure isconveyed along robotic arm 500 into male mechanism changer interface502. The male mechanism changer interface 502 also provides connections504 for transferring for pneumatic pressure to the IDM. Additionally,this embodiment of the mechanism changer interface provides foralignment sensors 505 that ensure that the male mechanism changerinterface 502 and its reciprocal female interface are properly aligned.

FIG. 5B illustrates an alternative view of male mechanism changerinterface 502 separated from robotic arm 500. As discussed with respectto FIG. 5A, male mechanism changer interface 502 provides for aflange-like male connector interface 503, pneumatic connectors 504, andalignment sensors 505. Additionally, an electrical interface 506 forconnecting electrical signals to the reciprocal interface on the IDM(not shown).

FIG. 5C illustrates a reciprocal female mechanism changer interfacecoupled to an instrument device manipulator for connecting with malemechanism changer interface 502 from FIGS. 5A and 5B. As shown in FIG.5C, instrument device manipulator 507 is coupled to a female mechanismchanger interface 508 that is configured to connect to male mechanismchanger interface 502 on robotic arm 500. Female mechanism changerinterface 508 provides for female receptacle interface 509 that isdesigned to couple to the flange-like male connector interface 503 ofmale mechanism changer interface 502. The female receptacle interface509 also provides a groove to grip the spherical indentations on themale connector interface 503. When pneumatic pressure is applied,spherical indentations on male connector 503 are extended, and maleconnector 503 and receptacle interfaces 509 securely couple the IDM 507to the robotic arm 500. Reciprocal female mechanism changer interface508 also provides with pneumatic connectors 510 to accept the pneumaticpressure conveyed from connectors 504.

FIG. 5D illustrates an alternative view of female mechanism changerinterface 508 from FIG. 5C. As discussed earlier, reciprocal mechanismchanger interface 508 contains a receptacle interface 509, pneumaticconnectors 510 for interfacing with mechanism changer interface 502 onrobotic arm 500. In addition, mechanism changer interface 508 alsoprovides for an electrical module 511 for transmitting electricalsignals—power, controls, sensors—to module 506 in mechanism changerinterface 502.

FIGS. 6, 7, 8A, and 8B illustrate interchangeable modules that may beoperated using system 400 from FIG. 4. FIG. 6 illustrates an embodimentof the present invention that uses a single port laparoscopic instrument601 connected through an instrument interface 602 on a single roboticarm 603 that is directed at the abdomen 604 of a patient 605.

FIG. 7 illustrates an embodiment of the present invention with two setsof robotic subsystems 701 and 704, each with a pair of arms 702, 703 and705, 706 respectively. Connected through instrument interfaces at thedistal end of arms 702, 703, 705, 706 are laparoscopic instruments 707,708, 709, 710 respectively, all instruments working together to performprocedures in an individual patient 711.

FIG. 8A illustrates an embodiment of the present invention with asubsystem 801 with a single robotic arm 802, where a microscope tool 804connected to the robotic arm 802 through an instrument interface 803. Insome embodiments, the microscopic tool 804 may be used in conjunctionwith a second microscope tool 805 used by a physician 806 to aid invisualizing the operational area of a patient 807.

FIG. 8B illustrates an embodiment of the present invention wheresubsystem 801 from FIG. 8A may be used in conjunction with subsystem 808to perform microsurgery. Subsystem 808 provides arms 809 and 810, eachwith microsurgical tools 811 and 812 connected through instrumentinterfaces on each respective arm. In some embodiments, the one or morearms may pick up and exchange tools at a table or other suitable holdingmechanism within reach of the robotic arm, such as a docking station.

In some embodiments, the mechanism changer interface may be a simplescrew to secure an associated IDM. In other embodiments, the mechanismchanger interface may be a bolt plate with an electrical connector.

6. Instrument Device Manipulator (IDM).

FIG. 9A illustrates a portion of a robotic medical system that includesa manipulator, in accordance with an embodiment of the presentinvention. System 900 includes a partial view of a robotic arm 901, anarticulating interface 902, an instrument device manipulator (“IDM”)903, and an endoscopic tool 904. In some embodiments, the robotic arm901 may be only a linkage in a larger robotic arm with multiple jointsand linkages. The articulating interface 902 couples IDM 903 to roboticarm 901. In addition to coupling, the articulating interface 902 mayalso transfer pneumatic pressure, power signals, control signals, andfeedback signals to and from the arm 901 and the IDM 903.

The IDM 903 drives and controls the endoscopic tool 904. In someembodiments, the IDM 903 uses angular motion transmitted via outputshafts in order to control the endoscopic tool 904. As discussed later,the IDM 903 may comprise a gear head, motor, rotary encoder, powercircuits, control circuits.

Endoscopic tool 904 may comprise a shaft 909 with a distal tip andproximal end. A tool base 910 for receiving the control signals anddrive from IDM 903 may be coupled to the proximal end of the shaft 909.Through the signals received by the tool base 910, the shaft 909 ofendoscopic tool 904 may be controlled, manipulated, and directed basedon the angular motion transmitted via output shafts 905, 906, 907, and908 (see FIG. 9B) to the tool base 910 of the endoscopic tool 904.

FIG. 9B illustrates an alternative view of the robotic medical systemdisclosed in FIG. 9A. In FIG. 9B, the endoscopic tool 904 has beenremoved from the IDM 903, to reveal the output shafts 905, 906, 907, and908. Additionally, removal of the outer skin/shell of IDM 903 revealsthe components below the IDM top cover 911.

FIG. 10 illustrates an alternative view of the independent drivemechanism from FIGS. 9A, 9B with a tension sensing apparatus inaccordance with an embodiment of the present invention. In cutaway view1000 of IDM 903, parallel drive units 1001, 1002, 1003, and 1004 are thestructurally largest components in the IDM 903. In some embodiments,from the proximal to the distal end, a drive unit 1001 may be comprisedof a rotary encoder 1006, a motor 1005, and a gear head 1007. Driveunits 1002, 1003, and 1004 may be constructed similarly—comprising ofmotors, encoders, and gear heads underneath the top cover 911. In someembodiments, the motor used in the drive unit is a brushless motor. Inother embodiments, the motor may be a direct current servo motor.

Rotary encoder 1006 monitors and measures the angular speed of thedriveshaft of motor 1005. In some embodiments, rotary encoder 1006 maybe a redundant rotary encoder. The structure, capabilities, and use ofan appropriate redundant encoder is disclosed in U.S. Provisional PatentApplication No. 62/037,520, filed Aug. 14, 2014, the entire contents ofwhich are incorporated by reference.

The torque generated by the motor 1005 may be transmitted to gear head1007 through a shaft coupled to the rotor of motor 1005. In someembodiments, the gear head 1007 may be attached to the motor 1005 inorder to increase torque of the motor output, at the cost of therotational speed. The increased torque generated by gear head 1007 maybe transmitted into gear head shaft 1008. Similarly, drive units 1002,1003, and 1004 transmit their respective torque out through gear headshafts 906, 907, and 908.

Each individual drive unit may be coupled to a motor mount at its distalend and a strain gauge mount towards its proximal end. For example, thedistal end of drive unit 1001 may be clamped to motor mount 1009 andstrain gauge mount 1010. Similarly, drive unit 1002 may be clamped tomotor mount 1011, while also both being clamped to strain gauge mount1010. In some embodiments, the motor mounts are constructed fromaluminum to reduce weight. In some embodiments, the strain gauge mountsmay be adhered to a side of the drive unit. In some embodiments, thestrain gauge mounts may be constructed from aluminum to reduce weight.

Electrical strain gauges 1012 and 1013 are potted and soldered to thestrain gauge mount 1010 and attached using screws to motor mounts 1009and 1011 respectively. Similarly, a pair of strain gauges (not shown)proximal to drive units 1003 and 1004 are potted and soldered to straingauge mount 1014 and attached to motor mounts 1015 and 1016 respectivelyusing screws. In some embodiments, the electrical strain gauges may beheld in place to their respective motor mount using side screws. Forexample, side screws 1019 may be inserted into motor mount 1009 to holdin place strain gauge 1012. In some embodiments, the gauge wiring in theelectrical strain gauges may be vertically arranged in order to detectany vertical strain or flex in the drive unit which may be measured ashorizontal displacement by the motor mount (1009, 1011) relative to thestrain gauge mount (1010).

The strain gauge wiring may be routed to circuits on the strain gaugemounts. For example, strain gauge 1012 may be routed to circuit board1017 which may be mounted on strain gauge mount 1010. Similarly, straingauge 1013 may be routed to circuit board 1018 which may be also mountedon strain gauge mount 1010. In some embodiments, circuit boards 1017 and1018 may process or amplify the signals from strain gauges 1012 and 1013respectively. The close proximity of circuit boards 1017 and 1018 tostrain gauges 1012 and 1013 helps to reduce the signal to noise ratio inorder to obtain more accurate readings.

FIG. 11A illustrates a cutaway view of the independent drive mechanismfrom FIGS. 9A, 9B, and 10 from an alternate angle. As shown in FIG. 11A,a portion of outer shell/skin 1101 has been cut away to reveal theinnards of IDM 903. As discussed earlier, the drive unit 1001 comprisesof motor 1005, rotary encoder 1006, and gear head 1007. The drive unit1001 may be coupled to the motor mount 1009 and passes through the topcover 911 through which the output shaft 905 may be driven at thedesired angular speed and torque. The motor mount 1009 may be coupled toa vertically aligned strain gauge 1012 using side screws. In addition tocoupling to motor mount 1009, the stain gauge 1012 may be potted intothe strain gauge mount 1010. In some embodiments, the output shaft 905includes a labyrinth seal over a gear head shaft.

FIG. 11B illustrates a cutaway view of the previously discussedindependent drive mechanism in combination with an endoscopic tool, inaccordance with an embodiment of the present invention. As shown in FIG.11B, endoscopic tool 904, mounted on IDM 903, contains pulleys that arelongitudinally aligned with the output shafts of the IDM 903, such aspulley 1102 which may be concentric with output shaft 905. Pulley 1102may be housed inside of a precision cut chamber 1103 within tool base910 such that the pulley 1102 may be not rigidly fixed inside chamber1103 but rather “floats” within the space in the chamber 1103.

The splines of the pulley 1102 are designed such that they align andlock with splines on output shaft 905. In some embodiments, the splinesare designed such that there may be only a single orientation for theendoscopic tool to be aligned with IDM 903. While the splines ensurepulley 1102 is concentrically aligned with output shaft 905, pulley 1102may also incorporate use of a magnet 1104 to position and axially holdthe floating pulley 1102 in alignment with output shaft 905. Locked intoalignment, rotation of the output shaft 905 and pulley 1102 tensions thepull wires within endoscopic tool 904, resulting in articulation ofshaft 909.

FIG. 12 illustrates an alternative view of the previously-discussedindependent drive mechanism with pull wires from an endoscopic tool inaccordance with an embodiment of the present invention. In someembodiments, the endoscopic tool may use pull wires in order toarticulate and control the shaft. In those embodiments, these pull wires1201, 1202, 1203, and 1204 may be tensioned or loosened by the outputshafts 905, 906, 907, and 908 respectively of the IDM 903. Accordingly,the pull wires may be robotically controlled via the control circuity inIDM 903.

Just as the output shafts 905, 906, 907, and 908 transfer force downpull wires 1201, 1202, 1203, and 1204 through angular motion, the pullwires 1201, 1202, 1203, and 1204 transfer force back to the outputshafts and thus to the motor mounts and drive units. For example,tension in the pull wires directed away from the output shaft results inforces pulling the motor mounts 1009 and 1011. This force may bemeasured by the strain gauges, such as 1012 and 1013, since the straingauges are both coupled to motor mounts 1009 and 1011 and potted in thestrain gauge mount 1010.

FIG. 13 illustrates a conceptual diagram that shows how horizontalforces may be measured by a strain gauge oriented perpendicular to theforces, in accordance with an embodiment of the invention. As shown indiagram 1300, a force 1301 may directed away from the output shaft 1302.As the output shaft 1302 is coupled to the motor mount 1303, the force1301 results in horizontal displacement of the motor mount 1303. Thestrain gauge 1304, coupled to both the motor mount 1303 and ground 1305,may thus experience strain as the motor mount 1303 causes the straingauge 1304 to flex (causing strain) in the direction of the force 1301.The amount of strain may be measured as a ratio of the horizontaldisplacement of the tip of strain gauge 1304 to the overall horizontalwidth of the strain gauge 1304. Accordingly, the strain gauge 1304 mayultimately measure the force 1301 exerted on the output shaft 1302.

In some embodiments, the assembly may incorporate a device to measurethe orientation of instrument device manipulator 903, such as aninclinometer or accelerometer. In combination with the strain gauges,measurements from the device may be used to calibrate readings from thestrain gauges, since strain gauges may be sensitive to gravitationalload effects resulting from their orientation relative to ground. Forexample, if instrument device manipulator 903 is oriented on its side,the weight of the drive unit may create strain on the motor mount whichmay be transmitted to the strain gauge, even though the strain may notresult from strain on the output shafts.

In some embodiments, the output signals from the strain gauge circuitboards may be coupled to another circuit board for processing controlsignals. In some embodiments, power signals are routed to the driveunits on another circuit board from that of processing control signals.

As discussed earlier, the motors in drive units 1001, 1002, 1003, and1004 ultimately drive output shafts, such as output shafts 905, 906,907, and 908. In some embodiments, the output shafts may be augmentedusing a sterile barrier to prevent fluid ingress into the instrumentdevice manipulator 903. In some embodiments, the barrier may make use ofa labyrinth seal (1105 from FIG. 11A) around the output shafts toprevent fluid ingress. In some embodiments, the distal end of the gearhead shafts may be covered with output shafts in order to transmittorque to a tool. In some embodiments, the output shafts may be clad ina steel cap to reduce magnetic conductance. In some embodiments, theoutput shafts may be clamped to the gear head shafts to assist transferof torque.

Instrument device mechanism 903 may also be covered in a shell or skin,such as outer shell/skin 1101. In addition to being aestheticallypleasing, the shell provides fluid ingress protection during operation,such as during medical procedures. In some embodiments, the shell may beconstructed using cast urethane for electromagnetic shielding,electromagnetic compatibility, and electrostatic discharge protection.

In an embodiment of the present invention, each of those output shaftsin individually tension may pull wires in an endoscopic tool that makesuse of steerable catheter technology. Tensile force in the pull wiresmay be transmitted to the output shafts 905, 906, 907 and 908 and downto a motor mount, such as motor mounts 1009 and 1011.

7. Endoscopic Tool Design.

In a preferred embodiment, robotic system 100 from FIG. 1 may drive atool customized for endolumenal procedures, such as endoscopic tool 118.FIG. 14 is an illustration of an endoscopic tool that may be used inconjunction with a robotic system 100 from FIG. 1, in accordance with anembodiment of the present invention. Endoscopic tool 1400 may bearranged around nested longitudinally-aligned tubular bodies, referredto as a “sheath” and a “leader”. The sheath 1401, the tubular tool withthe larger outer diameter, may be comprised of a proximal sheath section1402, a distal sheath section 1403, and a central sheath lumen (notshown). Through signals received in the sheath base 1404, the distalsheath portion 1403 may be articulated in the operator's desireddirection. Nested within the sheath 1401 may be a leader 1405 with asmaller outer diameter. The leader 1405 may comprise a proximal leadersection 1406 and a distal leader section 1407, and a central workingchannel. Similar to sheath base 1404, leader base 1408 controlsarticulation of the distal leader section 1407 based on control signalscommunicated to leader base 1408, often from the IDMs (e.g., 903 fromFIG. 9A).

Both the sheath base 1404 and leader base 1408 may have similar drivemechanisms, to which control tendons within sheath 1401 and leader 1405are anchored. For example, manipulation of the sheath base 1404 mayplace tensile loads on tendons in the sheath 1401, therein causingdeflection of distal sheath section 1403 in a controlled manner.Similarly, manipulation of the leader base 1408 may place tensile loadson the tendons in leader 1405 to cause deflection of distal leadersection 1407. Both the sheath base 1404 and leader base 1408 may alsocontains couplings for the routing of pneumatic pressure, electricalpower, electrical signals or optical signals from the IDMs to the sheath1401 and leader 1404.

Control tendons within the sheath 1401 and leader 1405 may be routedthrough the articulation section to an anchor positioned distal to thearticulation section. In a preferred embodiment, the tendons withinsheath 1401 and leader 1405 may consist of a stainless steel controltendon routed through a stainless steel coil, such as a coil pipe. Oneskilled in the arts would appreciate that other materials may be usedfor the tendons, such as Kevlar, Tungsten and Carbon Fiber. Placingloads on these tendons causes the distal sections of sheath 1401 andleader 1405 to deflect in a controllable manner. The inclusion of coilpipes along the length of the tendons within the sheath 1401 and leader1405 may transfer the axial compression back to the origin of the load.

Using a plurality of tendons, the endoscopic tool 1400 has the abilityto navigate lumens within the human body with ease by providing aplurality of degrees of freedom (each corresponding to an individualtendon) control at two points—distal sheath section 1403 and distalleader section 1407—along its length. In some embodiments, up to fourtendons may be used in either the sheath 1401 and/or leader 1405,providing up to eight degrees of freedom combined. In other embodiments,up to three tendons may be used, providing up to six degrees of freedom.

In some embodiments, the sheath 1401 and leader 1405 may be rolled 360degrees, providing for even more tool flexibility. The combination ofroll angles, multiple degrees of articulation, and multiple articulationpoints provides the surgeon with a significant improvement to theinstinctive control of the device as it navigates a tortuous path withinthe human body.

FIGS. 15A, 15B, 15C, 16A, and 16B generally illustrate aspects of arobotically-driven endoscopic tool, such a sheath 210 and leader 212from FIG. 2, in accordance with an embodiment of the present invention.FIG. 15A illustrates an endoscopic tool with sheath 1500 having distalend 1501 and proximal end 1502 and lumen 1503 running between the twoends. Lumen 1503 may be sized to slidingly receive a flexible endoscope(such as leader 1600 from FIG. 16). Sheath 1500 has walls 1504 withtendons 1505 and 1506 running inside the length of walls 1504 of sheath1500. Tendons 1505 and 1506 may slidingly pass through conduits 1507 and1508 in walls 1504 and terminate at distal end 1501. In someembodiments, the tendons may be formed from steel. Appropriatetensioning of tendon 1505 may compress distal end 1501 towards conduit1507, while minimizing bending of the helixed section 1510. Similarly,appropriate tensioning of tendon 1506 may compress distal end 1501towards conduit 1508. In some embodiments, lumen 1503 may not beconcentric with sheath 1500.

Tendons 1505 and 1506 and associated conduits 1507 and 1508 from sheath1500 from FIG. 15A preferably do not run straight down the entire lengthof sheath 1500, but helix around sheath 1500 along helixed section 1510and then run longitudinally straight (i.e., approximately parallel tothe neutral axis) along distal section 1509. It will be appreciated thathelixed section 1510 may begin from the proximal end of distal section1509 extending proximally down sheath 1510 and may terminate at anydesired length for any desired or variable pitch. The length and pitchof helixed section 1510 may be determined based on the desiredproperties of sheath 1500, taking into account desired flexibility ofthe shaft, and increased friction in the helixed section 1510. Tendons1505 and 1506 may run approximately parallel to central axis 1511 ofsheath 1500 when not in the helixed section, such as the proximal anddistal sections of the endoscope 1500.

In some embodiments, the tendon conduits may be at ninety degrees toeach other (e.g., 3-, 6-, 9- and 12-o'clock). In some embodiments, thetendons may be spaced one hundred and twenty degrees from each other,e.g., three total tendons. In some embodiments, the tendons may be notbe equally spaced. In some embodiments, they may be to one side of thecentral lumen. In some embodiments, the tendon count may differ fromthree or four.

FIG. 15B shows a three-dimensional illustration of an embodiment ofsheath 1500 with only one tendon for the purpose of clarifying thedistinction between non-helixed section 1509 and a variable pitchhelixed section 1510. While one tendon may be used, it may be preferableto use multiple tendons. FIG. 15C shows a three-dimensional illustrationof an embodiment of sheath 1500 with four tendons extending along distalsection 1509, variable pitch helixed section 1510.

FIG. 16A illustrates an endoscopic leader 1600 with distal end 1601 andproximal end 1602, that may be sized to slidingly reside within thesheath 1500 from FIG. 15. Leader 1600 may include at least one workingchannel 1603 passing through it. Proximal end 1502 of sheath 1500 andproximal end 1602 of leader 1600 are, respectively, operativelyconnected to tool bases 206 and 208 from FIG. 2 respectively. Tendons1604 and 1605 slidingly pass through conduits 1606 and 1607 respectivelyin walls 1608 and terminate at distal end 1601.

FIG. 16B illustrates the distal end 1601 of leader 1600, an exemplaryembodiment, that has imaging 1609 (e.g., CCD or CMOS camera, terminalend of imaging fiber bundle etc.), light sources 1610 (e.g., LED, opticfiber etc.) and may include at least one working channel opening 1603.Other channels or operating electronics 1606 may be provided alongleader 1600 to provide various known capabilities at the distal end,such as wiring to camera, insufflation, suction, electricity, fiberoptics, ultrasound transducer, EM sensing, and OCT sensing.

In some embodiments, the distal end 1601 of leader 1600 may include a“pocket” for insertion of a tool, such as those disclosed above. In someembodiments, the pocket may include an interface for control over thetool. In some embodiments, a cable, such as an electrical or opticalcable, may be present in order communicate with the interface.

In some embodiments, both sheath 1500 from FIG. 15A and leader 1600 fromFIG. 16A may have robotically-controlled steerable distal ends. Thestructure of sheath 1500 and leader 1600 enabling this control may besubstantially the same. Thus, discussion for the construction of sheath1500 will be limited to that of the sheath 1500 with the understandingthat the same principles apply to the structure of the leader 1600.

Therefore, tendons 1604 and 1605 and associated conduits 1606 and 1607from the leader 1600 from FIG. 16A do not run longitudinally straight(i.e., approximately parallel to the neutral axis) down the length ofleader 1600, but helix along different portions of leader 1600. As withthe helixed tendons and conduits in sheath 1500, the helixed sections ofleader 1600 may be determined based on the desired properties of theleader, taking into account desired flexibility of the shaft, andincreased friction in the helixed section. Tendons 1604 and 1605 runapproximately parallel to central axis of leader 1600 when not in thehelixed section.

The helixed section, as described more fully below, may help isolate thebending to the distal section, while minimizing any bending that occursalong the shaft proximal to the distal section. In some embodiments ofthe present invention, the helix pitch of the conduits in sheath 1500and leader 1600 may be varied along the length of the helixed section,which, as more fully described below will alter the stiffness/rigidityof the shaft.

The use of helixed conduits and helixed tendons in sheath 1500 andleader 1600 present significant advantages over previous flexibleinstruments without helixed conduits, particularly when navigatingnon-linear pathways in anatomical structures. When navigating curvedpathways, it may be preferable for sheath 1500 and leader 1600 to remainflexible over most of the lengths thereof, and to have a controllablysteerable distal end section, while also minimal secondary bending ofthe instrument proximal to the distal bending section. In previousflexible instruments, tensioning the tendons in order to articulate thedistal end resulted in unwanted bending and torqueing along the entirelength of the flexible instrument, which may be referred to as“muscling” and “curve alignment” respectively.

FIGS. 17A to 17D illustrates how prior art flexible instruments exhibitundesirable “muscling” phenomenon when tendons are pulled. In FIG. 17A,a previous endoscope 1700 may have four tendons or control wires alongthe length of the endoscope 1700 that run approximately parallel to theneutral axis 1701. Only tendons 1702 and 1703 are shown in cross sectiontraveling through conduits 1704 and 1705 (also known as control lumens)in the shaft wall, each of which are fixedly connected to a control ring1706 on the distal end of the endoscope 1700. Endoscope 1700 may beintentionally designed to have a bending section 1707 and shaft 1708. Insome flexible instruments, the shaft 1708 may incorporate stiffermaterials, such as stiffeners.

FIG. 17B illustrates an idealized articulation of bending section 1707.By pulling or exerting tension on tendon 1703, articulation of only thedistal bending section 1707 results in an amount represented by ϕ, wherethe length difference at the proximal ends of tendons 1702 and 1703would be a f(ϕ). In contrast, the shaft 1708 would remain straight alongthe neutral axis 1701. This may be achieved by having a proximal region1708 of a significantly higher stiffness than the distal region of 1707.

FIG. 17C illustrates the real world result from tensioning tendon 1703.As shown in FIG. 17C, pulling tendon 1703 results in compressive forcesalong the entire length of the shaft as the tension is non-localized. Inan idealized situation, were tendon 1703 along the neutral axis 1701,the entire compressive load would transmit equally down the central axisand most or all bending would occur at the bending section 1707.However, where the tendon 1703 runs along the periphery of the shaft1708, such as in endoscope 1700, the axial load is transferred off theneutral axis 1701 in the same radial orientation of the neutral axiswhich creates a cumulative moment along the neutral axis. This causesthe shaft 1708 to bend (depicted as θ), where the bend in the shaft 1708will be in the same direction as the bend in the bending section 1707.The length along conduit 1704 and conduit 1705 must change as theendoscope 1700 and distal bend section 1707 bend. The amount tendons1702 and 1703 extend from the proximal end is f(ϕ,θ), as tendon 1703will need to shorten and tendon 1702 will need to lengthen. Thisphenomenon, where the shaft 1707 and distal bending section 1708 bendfrom pulling tendon 1703, is referred to as “muscling.”

FIG. 17D illustrates the forces that contribute to muscling inthree-dimensions. As shown by FIG. 17D, tensioning tendon 1703 alongendoscope 1700 causes the tendon 1703 to directionally exert forces 1712towards one side of the instrument. The direction of forces 1712 reflectthat the tension in tendon 1703 causes the tendon to seek to follow astraight line from the tip of the distal bending section 1707 to thebase of the shaft 1708, i.e., the lowest energy state as represented bythe dotted line 1713. As will be appreciated, if the shaft 1708 is rigid(i.e., not susceptible to bending under the applicable forces), only thedistal bending section 1707 will bend. However, in many applications itis not desirable to make the shaft rigidity sufficiently different fromthe distal end to adequately minimize the muscling phenomenon.

FIGS. 17E to 17H illustrate how previous flexible instruments sufferfrom curve alignment phenomenon during use in non-linear pathways. FIG.17E shows a previous flexible endoscope 1700 at rest within a non-linearpath, represented by having a bend t along the shaft 1708 of endoscope1700. For example, this may result from the instrument navigating past abend in the bronchial lumens. Due to the non-linear bend, tendons 1702and 1703 in endoscope 1700 need to lengthen or shorten at the proximalend by a length to accommodate the non-linear bend, which length isrepresented by F(τ). Extension and compressive forces exist on thelumens/conduits at the top and bottom of the bend, as depicted by arrows1709 (extension forces) and 1710 (compressive forces) respectively.These forces exist because the distance along the top of the bend islonger than the neutral axis, and the distance along the inside of thebend is shorter than the neutral axis.

FIG. 17F illustrates the mechanics of articulating the distal bendingsection 1707 of the endoscope 1700 in the same direction as bend t,where one would pull tendon 1703. This results in compressive forcesalong the length of the flexible instrument (as previously described),and tendon 1703 also exerts downward forces against the non-linearconduit through which it passes, which applies an additive compressionin the shaft 1708 previously compressed by the anatomical tortuosity.Since these compressive leads are additive, the shaft 1708 will furtherbend in the same direction as the distal bending section 1707. Theadditional compressive force along the non-linear conduit may beundesirable because: (i) it may unintentionally force the flexibleinstrument against the anatomy; (ii) potential for injury distracts theoperator because he/she has to constantly monitor what the shaft isdoing, when he/she should be able to “assume” the anatomy is governingthe profile of the instrument shaft; (iii) it is an inefficient way tobend the instrument, (iv) it is desired to isolate bending at the distalsection to aid in predictability and controllability (i.e., idealinstrument will have bending section that bends as commanded and is nota function of the anatomical non-linear path), and (v) it forces a userto pull on a tendon 1103 an unpredictable additional length (ϕ+θ+τ).

FIG. 17G illustrates a scenario where one desires to articulate thedistal end opposite to bend t, requiring pulling tendon 1702. Pullingtendon 1702 applies a compressive load 1711 along the top of the curve,which is in contrast to the extension loads for the bend in its restingstate as shown in FIG. 17E. Tendons 1702 will attempt to return to itslowest energy state, i.e., where the compressive load 1711 rests on theinside of the bend t, and cause the shaft 1708 to rotate in thedirection of the arrow 1712 so that the tendon 1702 rests on the insideof the bend T. As shown in FIG. 17H, the rotation 1712 from tension ontendon 1702 moves the compressive load 1711 to return to the inside ofthe bend and causes the distal bending section 1707 to curl back in thedirection of bend t, resulting in articulation opposite to thatintended. The tension on tendon 1702, and the ensuing rotation 1712, inpractice returns endoscope 1700 to the same state as in FIG. 17F. Thephenomenon where the distal end articulation curves back towards bend tis known as “curve alignment.” It will be appreciated that curvealignment results from the same forces that cause muscling, whereinthose forces result in undesirable lateral motion in the case ofmuscling and undesirable rotational motion in the case of curvealignment. It is noted that the discussions of the theory of musclingand curve alignment is provided not by way of limitation, andembodiments of the present invention are not in any way limited by thisexplanation.

FIGS. 171 and 17J illustrate how the muscling and curve alignmentphenomena is substantially resolved through the provision of a helixedsection in an embodiment of the present invention, such as 1510 in FIG.15. As shown in FIG. 17I, helixing the control lumens around endoscope1700, such as in helixed section 1510 from FIG. 15, radially distributescompressive loads 1714 from a single tendon 1715 around endoscope 1700.Because a tensioned tendon 1715 symmetrically transmits the compressiveload 1714 in multiple directions around the neutral axis, the bendingmoments imposed on the shaft are also symmetrically distributed aroundthe longitudinal axis of the shaft, which counterbalance and offsetopposing compressive and tensile forces. The distribution of the bendingmoments results in minimal net bending and rotational forces, creating alowest energy state that is longitudinally parallel to the neutral axis,as represented by the dotted line 1816. This eliminates or substantiallyreduces the muscling and curve alignment phenomena.

In some embodiments, the pitch of helixing can be varied to affectfriction and the stiffness of the helixed section. For example, thehelixed section 1510 may be shorter to allow for a larger non-helixedsection 1509, resulting in a larger articulating section and possiblyless friction.

Helical control lumens, however, create several trade-offs. Helicalcontrol lumens still do not prevent buckling from tension in thetendons. Additionally, while muscling is greatly reduced,“spiraling”—the curving of the shaft into a spiral, spring-like patterndue to tension in the tendons—is very common. Moreover, helical controllumens requires compensation for additional frictional forces as thetendon travels through the lumen for longer distances.

FIG. 18 illustrates the structure of a flexible endoscopic tool with anaxially stiff tube within a lumen, in accordance with an embodiment ofthe present invention. In FIG. 18, a section of an endoscopic tool has asingle lumen 1801 with a pull wire 1802 wrapped in a helical patternaround the shaft 1800. Inside the lumen, an axially stiff tube 1803“floats” around the pull wire 1802 and within the lumen 1801. Anchoredat the beginning and end of the helical portion of the shaft 1800, thefloating tube 1803 extends and compresses in response to tension in pullwire 1802 and external tortuosity, relieving the walls of lumen 1801from the extension and compression forces. In some embodiments, the tube1803 may be anchored by control rings at the beginning and end of thelumen. Alternatively, tube 1803 may be anchored using solder, welding,gluing, bonding, or fusing methods to the beginning and end of thelumen. In some embodiments, geometric engagement, such as flaredgeometries, may be used to anchor tube 1803. In various embodiments, thetube 1803 may be formed from hypodermic tubes, coil pipes, Bowdencables, torque tubes, stainless steel tubes, or nitinol tubes.

The embodiment in FIG. 18 may be constructed by fixedly attaching thetubes to a distal end piece and proximal end piece and collectivelytwisting the tubes by rotating either or both end pieces. In thisembodiment, the rotation of the end piece(s) ensures that the tubes arehelixed in the same pitch, manner, and orientation. After rotation, theend pieces may be fixedly attached to the lumen to prevent furtherrotation and restrict changes to the pitch of the helixing.

FIG. 19 illustrates the structure of a helical pattern within a lumen ofa flexible endoscopic tool, in accordance with an embodiment of thepresent invention. In FIG. 19, lumen 1900 contains structures 1901 and1902 that form a helical or spiraled pattern along its walls. Inpreferred embodiments, the structures are formed from materials that areaxially stiff and tube-like in shape. In some embodiments, thestructures may be formed from hypodermic tubes (“hypo tube”), coilpipes, or torque tubes. As shown by structures 1901 and 1902, thestructures may have different starting points along the walls of lumen1900. The materials, composition, and characteristics of structures 1901and 1902 may also be selected and configured for desired stiffness andlength. The pitch of the helical pattern formed by structures 1901 and1902 may also be configured for a desired stiffness and flexibility oflumen 1900. In some embodiments, lumen 1900 may be the main centrallumen of a flexible endoscope, such as leader 1600 from FIG. 16.

FIG. 20A illustrates an endoscopic tool from a robotic endolumenalsystem, in accordance with an embodiment of the present invention.Endoscopic tool 2000 may comprise of a flexible shaft section 2001proximal to a support base (not shown) and a flexible articulatingsection 2002 coupled to a distal tip 2003. Similar to the leader 2005,endoscopic tool 2000 may be articulated by placing tensile loads ontendons within the shaft.

FIG. 20B illustrates an alternative view of endoscopic tool 2000 fromFIG. 20A. As shown in FIG. 20B, the distal tip 2003 may comprise aworking channel 2004, four light emitting diodes 2005, and a digitalcamera 2006. In conjunction with the LEDs 2005, the digital camera 2006may be used, for example, to capture real-time video to assist withnavigation within anatomical lumens. In some embodiments, the distal tip2003 may comprise an integrated camera assembly which houses a digitalimaging means and illumination means.

The working channel 2004 may be used for the passage of intraoperativeinstruments, such as bending flexures for precise articulation at anoperative site. In other embodiments, working channels may beincorporated to provide additional capabilities such as flush,aspiration, illumination or laser energy. The working channel may alsofacilitate the routing of control tendon assemblies and other lumensneeded for the aforementioned additional capabilities. The workingchannel of the endoscopic tool may also be configured to deliver avariety of other therapeutic substances. Such substances may becryogenic for ablation, radiation, or stem cells. These substances maybe precisely delivered precisely to a target site using the insertion,articulation, and capability of the endoscopic tool of the presentinvention. In some embodiments, the working channel may be as small at1.2 millimeters in diameter.

In some embodiments, an electromagnetic (EM) tracker may be incorporatedinto the distal tip 2003 in order to assist with localization. As willbe discussed later, in a static EM field generator may be used todetermine the location of the EM tracker, and thus distal tip 2003 inreal-time.

Images from camera 2006 may be ideal for navigating through anatomicalspaces. Thus, obscuring of the camera 2006 from internal bodily fluids,such as mucus, may cause problems when navigating. Accordingly, thedistal end 2003 of endoscopic tool 2000 may also include means forcleaning the camera 2006, such as means for irrigation and aspiration ofthe camera lens. In some embodiments, the working channel may contain aballoon that may be inflated with fluid around the camera lens andaspirated once the lens was clear.

The endoscopic tool 2000 enables the delivery and manipulation of smallinstruments within the endolumenal space. In a preferred embodiment, thedistal tip may be miniaturized in order to perform endolumenalprocedures, maintaining an outer diameter of no more than threemillimeters (i.e., nine French).

FIG. 21 illustrates the distal end of an endoscopic tool, in accordancewith an embodiment of the present invention. As in FIG. 21A, endoscopictool 2100 includes a distal end 2101 with an outer casing 2102. Casing2102 may be constructed from a number of materials including stainlesssteel and polyether ether ketone (PEEK). The distal end 2101 may bepacked with a working channel 2103 for slidingly providing tool accessand control. The distal end 2101 may also provide for an array of lightemitting diodes 2104 for illumination with use of the camera 2105. Insome embodiments, the camera may be part of a larger sensor assemblythat includes one or more computer processors, a printed circuit board,and memory. In some embodiments, the sensor assembly may also includeother electronic sensors such as gyroscopes and accelerometers (usagediscussed later).

8. Endoscopic Tool Manufacture.

In background, steerable catheters are traditionally manufactured bybraiding wires or fibers, i.e., braid wire, around a process mandrelwith pull lumens in a braiding machine, i.e., braider, and a polymerjacket applied over the braid wires. Embodiments of the sheath andleader endoscopic tools may be constructed using aspects of steerablecatheter construction methodologies.

FIG. 22 illustrates a flowchart for a method of constructing anendoscopic device with helixed lumens, in accordance with an embodimentof the present invention. To start, in step 2201, a main process mandrelmay be selected to create a cavity in the endoscope for a central lumenthat may be used a working channel. Supplemental mandrels may beselected to create cavities in the wall of the endoscope for use ascontrol (pull) lumens. The main process mandrel may exhibit larger outerdiameters (OD) than the supplemental mandrels to reflect the relativesize differential between a working channel and pull lumens. Thesupplemental mandrels may be constructed a metal or thermoset polymerthat may or may not be coated with a lubricious coating, such as PTFE.

In step 2202, the main process mandrel may be inserted into a feed tubeof a braider that rotates relative to a fixed braid cone support tubeand braid cone holder. Similarly, the supplemental mandrels may also beinserted into the feed tube in parallel fashion to the main processmandrel. In traditional endoscope construction, smaller supplementalmandrels are passed through the center of the horn gears for braiding.

In step 2203, using a puller with a tread, the main process mandrel maybe advanced through the feed tube. As the main process mandrelprogresses, it eventually emerges through a center hole in a nose cone.Similarly, the supplemental mandrels are advanced through to also emergethrough outer holes in the nose cone. This contrasts with traditionalendoscope construction, where supplemental mandrels are typicallyadvanced through separate feed tubes to emerge from the center of thehorn gears.

In step 2204, the main process mandrel and supplemental mandrels arebraided together using braid wire as they emerge through the nose cone.The nose cone provides a round, smooth shape on which the braid wirefrom the surrounding horn gears may easily slide around the main processmandrel during the braiding process. As both the main process mandreland supplemental mandrels emerge from the nose cone, the nose conerotates, ensuring that the supplemental mandrels in the outer holes arebraided in a spiraled fashion around the main process mandrel. As themain process mandrel and supplemental mandrels are being braidedtogether, the horn gears translate and rotate to lay braid wire aroundboth the main process mandrel and supplemental mandrels at apre-determined pattern and density.

This method of braiding is significantly different from traditionalmethods of endoscope construction, where the nose cone is typically heldin a position that is radially fixed relative to the braid cone holderusing a set screw keyed to the braid cone holder. Thus, specializedhardware is required for the braiding process in order to manufacturecatheter-like endoscopes with helical control lumens.

FIG. 23 illustrates a specialized system for manufacturing an endoscopewith helical pull lumens, in accordance with an embodiment of thepresent invention. In system 2300, the nose cone 2301 may be fixedlycoupled to a rotating feed tube 2302 using a set screw that holds thenose cone 2301 in a fixed position relative to the feed tube 2302. Thus,nose cone 2301 rotates as the feed tube 2302 rotates. In contrast,traditional systems typically use a set screw to fixedly couple the nosecone 2301 to the braid cone support holder 2305, which does not rotate.

The center hole 2303 of the nose cone 2301 may be aligned with therotating feed tube 2302 in order to smoothly pull the main processmandrel 2304 through both structures. In some embodiments, the rotatingfeed tube 2302 has an outside diameter less than the interior diameterof the braid cone support tube 2306, also known as a mandrel guide tube,and an interior diameter larger than the circumferential space of thecenter hole 2303 of the nose cone 2301. The rotating feed tube 2302 maygenerally be large enough for the main process mandrel 2304 and thesupplemental mandrels to be passed through to the nose cone 2301 withoutentanglement. In some embodiments, the rotating feed tube 2302 may belong enough to pass through the center of the horn gears of the braider.In some embodiments, the rotating feed tube 2302 may be attached to amechanism that may hold bobbins of material for the supplementalmandrels that will be passed through the feed tube 2302 to supplementalholes around the nose cone 2301.

In some embodiments, the feed tube 2302 may be attached to a drivemechanism that controls the rate of rotation of the feed tube 2302 andthus the rotation of the nose cone 2301. In some embodiments, the drivemechanism may be a rotating gear 2307. As the braider is braiding thebraid wires 2308 around the main process mandrel 2304, the drivemechanism is either geared to the braider itself or independentlycontrolled to vary or hold constant the rate of rotation of the rotatingfeed tube 2302 and thus the rate of rotation of the nose cone 2301. Therate of rotation and the rate of braiding will govern the pitch of thesupplemental mandrels on the main process mandrel 2304. As discussedearlier, this may affect the flexibility, stiffness, and “pushability”of the device.

FIG. 24 illustrates a specialized nose cone for manufacturing helicallumens in an endoscopic device, in accordance with an embodiment of thepresent invention. Rotating the nose cone 2400 at the same time that themain process mandrel 2401 is pulled through the nose cone 2400 allowsfor supplemental mandrels 2402, 2403, and 2404 to be applied in ahelical pattern around the mandrel 2401 through supplemental holes 2405,2406, and 2407 respectively that surround the center hole 2408, similarto how the horn gears braid the braid wire around the main processmandrel 2401.

In another embodiment, varying the circumferential orientation of thepull lumens may change the stiffness of the helical section of theendoscope. In manufacture, this may be achieved by altering the pitch ofthe supplemental, spiraling mandrels. As the pitch (i.e., the angle offthe longitudinal axis) of the mandrels increases, the bending stiffnessof the braided composite decreases. Conversely, as the pitch of thesupplemental mandrels decreases, the bending stiffness increases. Asshown in FIG. 15B, in some embodiments, the pitch of the supplementalmandrels may be varied within the helixed portion (1510). In thoseembodiments, the bending stiffness of the braided composite may varyeven within the helixed portion.

Returning to FIG. 22, in step 2205, upon completion of the braidedprocess, a polymer coating or jacket may be sheathed, heated, and bondedto the braiding composite. The polymer coating may also be applied in anover-extrusion or a film-cast process. In step 2206, after bonding, themandrels may be removed from the braided composite to create a centrallumen or working channel (main process mandrel) for camera and lighttools, and several control lumens (supplemental mandrels) for steeringcontrol. Having removed the mandrels, the braided composite may befinished for completion (2207).

During the braiding process, the braiding machine may be stopped to makealterations to the braided composite. In some embodiments, onealteration may be the addition of straight wires or reinforcement rods.Reinforcement rods may significantly change the buckling, axial andbending stiffness of a braided laminated composite. Reinforcement rodsmay be particularly helpful for longer endoscopes which may requirespecialized anti-buckling construction or manual assistance to reducethe buckling of the device so that it may be inserted into a patient. Insome embodiments, the braiding machine may be configured to selectivelybraid reinforcement rods that may be pulled from holes in the nose coneonto the main process mandrel, where the reinforcement rods are capturedand held in place by the braid wire. The absence of reinforcement rodsin the distal region of the resulting endoscope preserves the device'sflexibility in the distal end while increasing the stiffness in theproximal region. This combination of properties makes the resultingendoscope easier for a physician to navigate, insert, and push thedevice into an endolumenal cavity of a patient.

Applying supplemental mandrels onto a main process mandrel using holesin a rotating nose cone provides a number of manufacturing advantages.By using holes in the nose cone, the mandrels are not pushed from thehorn gears. Pushing mandrels from the center of the individual horngears, which are also responsible for weaving the braid wire, results inthe mandrels being interwoven with the braid wire, which locks theresulting braid matrix in place longitudinally. This form ofconstruction, known as “zero degree construction,” limits the ability ofthe manufacturer to adjust the braid matrix for desirable flexibility orhoop strength. In zero degree construction, the supplemental mandrel isnecessarily confined in an “over-under manner” by the braid, resultingin all clockwise braided braid wire being woven “over” the supplementalmandrels, while all counter-clockwise braided braid wire is woven“under” the supplemental mandrels. As zero degree construction locks thesupplemental mandrels in place radially, it may be undesirable wherevarying the pitch of the supplemental mandrel along the main processmandrel is required.

Additionally, use of the horn gears as a pass-through for thesupplemental mandrels limits the number of supplemental mandrels thatmay be applied to the main process mandrel. For example, a sixteencarrier braider can apply up to eight mandrels, a twenty-four carrierbraider can only have up to twelve mandrels. In contrast, use of holesin the nose cone allows any number of mandrels to be passed through tothe main process mandrel.

In some embodiments, the supplemental mandrels may be applied to themain process mandrel without the benefit of a second, outer layer ofbraid wire. Instead, the supplemental mandrels may be applied withoutbraid wire. In those embodiments, the bonded/fused polymer jacket mayhold the mandrels, and thus lumens in place. Alternatively, in someembodiments, the mandrels may be held in place using a casting aroundthe braided composite. Since the outer braid layer is absent from themanufacturing endoscopic tool, the diameter and circumference of thedevice cross-section is reduced. Alternatively, the supplementalmandrels may be held in place by sleeving a polymer jacket over the mainprocess mandrel. In some embodiments, the casting may be the samematerial as the exterior material for the endoscopic tool.

In some embodiments, the supplemental mandrels may be braided onto themain process mandrel much like the braid wire. For example, in someembodiments, the supplemental mandrels may be braided using the evennumbered horn gears, while held in place by braid wire braided using theodd numbered horn gears. In this way, the supplemental mandrels, andthus the lumens may be woven into the walls of the central lumen. As anadded benefit, embodiments manufactured using this means also tend tohave lower circumferential area.

Alternatively, in some embodiments, the helixed lumen structures may bemanufactured using extruded molds. These molds may generate the helixedlumen structures to create a jacket from PTFE, pebax, polyurethane, andnylon. In some embodiments, the extruded structures may be formed usinga mold around a braided mandrel.

In some embodiments, the helical lumen construction may be performed byrotating the main process mandrel as it is being drawn through thebraider. By rotating the main process mandrel, instead of the nose cone,the supplemental mandrels may be drawn through either a fixed nose coneor through the center of the horn gears during the braiding process. Inthis embodiment, the nose cone may be fixedly coupled to the nose coneholder and the main process mandrel is rotated as it drawn through thenose cone.

Construction of sheath 1500 from FIG. 15 and leader 1600 from FIG. 16are substantially the same. Thus, one of skill in the art wouldunderstanding that the same principles apply to both tools.

9. Endolumenal Navigation.

In an embodiment of the present invention, navigation of the endoscopictool through anatomical lumens may involve use of computer-generatedthree-dimensional maps based on a collection of two-dimensional imagescreated by low dose computerized tomography (CT) scans. Two-dimensionalCT scans, each representing a cutaway view of the patient's internalanatomy, may be collected during pre-operative procedures. These scansmay be analyzed to determine cavities and anatomical spaces within thepatient, such as branches of a lung or the path of a urethra.

Having been analyzed to determine the relevant anatomical spaces withinthe patient, the spaces may be expressed as lumens with centerlinecoordinates, i.e., coordinates representing the center of the lumen, inthree-dimensional space. The volume of those cavities may be representedas a specific measurement of diameter distance at each centerlinecoordinate. By tracking the centerline and the corresponding diameterdistance measurements, a computer-generated model of a three-dimensionallumen may be generated. Grid coordinate data may thus be used to expressthree-dimensional spaces and cavities that represent the patient'sanatomy.

FIG. 25 illustrates the relationship between centerline coordinates,diameter measurements and anatomical spaces. In FIG. 25A, anatomicallumen 2500 may be roughly tracked longitudinally by centerlinecoordinates 2501, 2502, 2503, 2504, 2505, and 2506 where each centerlinecoordinate roughly approximates the center of the lumen. By connectingthose coordinates, as shown by “centerline” 2507, the lumen may bevisualized. The volume of the lumen may be further visualized bymeasuring the diameter of the lumen at each centerline coordinate. Thus2508, 2509, 2510, 2511, 2512, and 2513 represent the measurements of thelumen 2500 at coordinates 2501, 2502, 2503, 2504, 2505, and 2506.

In FIG. 25B, lumen 2500 may be visualized in three-dimensional space byfirst locating the centerline coordinates 2501, 2502, 2503, 2504, 2505,and 2506 in three-dimensional space based on centerline 2507. At eachcenterline coordinate, the lumen diameter may be visualized as atwo-dimensional circular space with diameters 2508, 2509, 2510, 2511,2512, and 2513. By connecting those two-dimensional circular spaces inthree-dimensions, lumen 2500 may be approximated as three-dimensionalmodel 2514. More accurate approximations may be determined by increasingthe resolution of the centerline coordinates and measurements, i.e.,increasing the density of centerline coordinates and measurements for agiven lumen or subsection. Centerline coordinates may also includemarkers to indicate point of interest for the physician, includinglesions.

Having expressed, and subsequently generated, a three-dimensional modelof the anatomical space, a pre-operative software package may also beused to analyze and derive an optimal navigation path based on thegenerated module. For example, the software package may derive shortestpath to a single lesion (marked by a centerline coordinate) or severallesions. This path may be presented to the operator intra-operativelyeither in two-dimensions or three-dimensions depending on the operator'spreference.

FIG. 26 illustrates a computer-generated three-dimensional modelrepresenting an anatomical space, in accordance with an embodiment ofthe invention. As discussed earlier, model 2600 may be generated usingcenterline 2601 that was obtained by reviewing CT scans that wereperformed preoperatively. In some embodiments, computer software may beable to map the optimum path 2602 for the endolumenal system to accessan operative site 2603 within model 2600, and thus the correspondinganatomical space. In some embodiments, the operative site 2603 may belinked to an individual centerline coordinate 2604, which allows acomputer algorithm to topologically search the centerlines of model 2600for the optimum path 2602 for the endolumenal system.

Tracking the distal end of the endoscopic tool within the patient'sanatomy, and mapping that location to placement within a computer model,enhances the navigational capabilities of the endolumenal system. Inorder to track the distal working end of the endoscopic tool, i.e.,“localization” of the working end, a number of approaches may beemployed, either individually or in combination.

In a sensor-based approach to localization, a sensor, such as anelectromagnetic (EM) tracker, may be coupled to the distal working endof the endoscopic tool to provide a real-time indication the progressionof the endoscopic tool. In EM-based tracking, an EM tracker, embedded inthe endoscopic tool, measures the variation in the electromagnetic fieldcreated by one or more static EM transmitters. The transmitters (orfield generators), may be placed close to the patient to creates a lowintensity magnetic field. This induces small-currents in sensor coils inthe EM tracker, which are correlated to the distance and angle betweenthe sensor and the generator. The electrical signal may then bedigitized by an interface unit (on-chip or PCB) and sent viacables/wiring back to the system cart and then to the command module.The data may then be processed to interpret the current data andcalculate the precise location and orientation of the sensor relative tothe transmitters. Multiple sensors may be used at different locations inthe endoscopic device, for instance in leader and sheath in order tocalculate the individual positions of those components. Thus, based onreadings from an artificially-generated EM field, the EM tracker maydetect changes in field strength as it moves through the patient'sanatomy.

FIG. 27 illustrates a robotic endolumenal system that makes use of anelectromagnetic tracker in combination with an electromagnetic fieldgenerator, in accordance with an embodiment in the present invention. Asrobotic system 2700 drives a robotically driven endoscopic tool 2701into the patient 2702, an electromagnetic (EM) tracker 2703 at thedistal end of the endoscopic tool 2701 may detect an EM field generatedby EM field generator 2704. The EM readings of the EM tracker 2703 maybe transmitted down the shaft of the endoscopic tool 2701 to the systemcart 2705 and to command module 2706 (which contains relevant softwaremodules, a central processing unit, a data bus and memory) forinterpretation and analysis. Using the readings from EM tracker 2703,display modules 2707 may display the EM tracker's relative positionwithin a pre-generated three-dimensional model for review by theoperator 2708. The embodiments also provide for the use of other typesof sensors, such as fiber optic shape sensors. While a variety ofsensors may be used for tracking, the choice of sensor may be inherentlylimited based on (i) the size of the sensor within the endoscopic tooland (ii) the cost of manufacturing and integration the sensor into theendoscopic tool.

Prior to tracking a sensor through the patient's anatomy, the trackingsystem may require a process known as “registration,” where the systemfinds the geometric transformation that aligns a single object betweendifferent coordinate systems. For instance, a specific anatomical siteon a patient has two different representations in the CT modelcoordinates and in the EM sensor coordinates. To be able to establishconsistency and common language between these coordinate systems, thesystem needs to find the transformation that links these tworepresentations, i.e., registration. In other words, the position of theEM tracker relative to the position of the EM field generator may bemapped to a three-dimensional coordinate system to isolate a location ina corresponding three-dimensional model.

In some embodiments, registration may be performed in several steps.FIG. 28 illustrates a flow diagram for a registration process, inaccordance with an embodiment of the present invention. To start, instep 2801, the operator must first position the working end of theendoscopic tool at a known starting location. This may involve usingvideo imagery data from the endoscopic camera to confirm the startinglocation. Initial positioning may be accomplished by identifyinganatomical features through a camera located at the working end of theendoscope. For example, in bronchoscopy, registration may be performedby locating the base of the trachea, distinguished by locating the twomain bronchial tubes for the left and right lung. This location may beascertained using video images received by the camera in the distal endof the endoscopic. In some embodiments, the video data may be comparedto different cross sectional views of a pre-generated computer model ofthe patient's anatomy. By sorting through cross-sectional views, thesystem may identify the location associated with the cross-section withthe smallest amount of differences, or “errors,” to find the “match.”

In step 2802, the operator may “drive” or “extend” the endoscopic toolinto unique anatomical spaces that have already been mapped. Forexample, in bronchoscopy, the operator may drive the endoscope downunique bronchial paths from the base of the trachea. Because the base ofthe trachea splits into two bronchial tubes, an operator may drive theendoscopic tool into one tube and track the working end of theendoscopic tool using an EM tracker.

In step 2803, the operator monitors the relative travel of theendoscopic tool. Monitoring of the endoscopic tool may make use ofeither the EM tracker or fluoroscopy to determine relative movement ofthe endoscopic tool. Evaluation of the relative displacement of theworking end of the endoscopic tool may be compared the computer modelgenerated from pre-operative CT scan data. In some embodiments, therelative movement may be matched with centerlines in the computer model,where the transformation matrix leads to the least error is the correctregistration. In some embodiments, the system and operator may trackinsertion data (discussed below) and orientation data from anaccelerometer and/or gyroscope (discussed below).

In step 2804, the operator may decide to drive into more anatomicalspaces (2802) and collect more locational information (2803) prior tocomparing and analyzing the positional data. For example, inbronchoscopy, the operator retract the endoscope from one bronchial tubeback the tracheal tube and drive the endoscope into another bronchialtube in order to collect more positional data. Once the operator issatisfied, the operator may stop driving (2802) and monitoringpositional data (2803) and proceed to process the data.

In step 2805, the system may analyze the collected positional data andcompare the data to pre-generated computer models to register thedisplacement of the endoscope within patient's anatomy to the model.Therefore, by comparing the movement in the patient's anatomy to thethree-dimensional model of the patient's anatomy, the system may be ableto register the tracker relative to both spaces—three-dimensionalcomputer model vs. patient anatomical space. After analysis, theregistration process may be complete (2806).

In some cases, it may be necessary to perform a “roll registration” inorder to confirm the orientation of the endoscopic tool. This may beparticularly important in step 2801 prior to driving into un-registeredanatomical spaces. In bronchoscopy, proper vertical orientation ensuresthat the operator may distinguish between the right and left bronchi.For example within the base of the trachea, images of the left and rightbronchi may appear very similar regardless of whether the camera isoriented at zero degrees or one-hundred eighty degrees. Rollregistration may also be important because the kinematics of theendoscopic tool typically results in a slight rotation during tortuousnavigation within a patient.

Roll registration may be important at the operative site when theworking channel may be occupied by the sensor. For example, inembodiments with only a single working channel, upon reaching theoperative site, the physician may need to remove the EM tracker from theendoscopic tool in order to make use of another tool, such as a grasperor forceps. Upon removal, however, the system may lose its localizationcapabilities without the EM tracker. Thus, when ready to leave theoperative region, insertion of the EM tracker may require that the rollregistration be again performed to ensure proper orientation.

In some embodiments, the rotation of the endoscopic tool may be trackedusing an accelerometer mounted within the distal working end of thedevice. Use of an accelerometer to detect gravitational forces on theendoscope provides information regarding the location of the endoscopictool relative to the ground. The location of the ground relative to theendoscope may be used to solve certain ambiguities. In bronchoscopy, forexample, knowing the orientation (0 or 180 degrees) of the distal cameraof the endoscope would help determine the appropriate bronchial branchat the start. During navigation, data from the accelerometer to trackthe direction of gravity, and thus orientation, may also be used toauto-correct the camera image displayed on the control console, ensuringthat the displayed image is always oriented vertically.

In a preferred embodiment, a 3-axis MEMS-based sensor chip with anaccelerometer may be coupled near the tip of the endoscopic device, onthe same printed circuit board as the digital camera. The accelerometermeasures the linear acceleration along the three different axes tocalculate the velocity and direction of the catheter tip. Itaccelerometer also measures the direction of gravity and thus providesabsolute information about the orientation of the endoscopic device. Theaccelerometer readings re be transmitted using digital or analog signalsthrough a communication protocol like I2C. The signal may be transmittedthrough wiring to the proximal end of the catheter and from there to thesystem cart and command module for processing.

In a three-axis sensor, the accelerometer may be able to determinelocation of the ground relative to the endoscope. If the endoscope doesnot roll or bend up to ninety degrees, a two axis accelerometer could bealso be useful. Alternatively, a one-axis sensor may be useful if theaxis of the accelerometer remains perpendicular to the direction ofgravity, i.e., perpendicular to the ground. Alternatively, a gyroscopemay be used to measure the rate of rotation, which may then be used tocalculate the articulation of the endoscopic device.

Some embodiments make use of an EM tracker in combination with theaccelerometer to supplement any orientation readings from theaccelerometer. In some embodiments, use of fluorescopy to track theendoscopic tool may also supplement the registration process. As knownin the art, fluoroscopy is an imaging technique that uses X-rays toobtain real-time moving images of the internal structures of a patientthrough the use of a fluoroscope. Two-dimensional scans generated byfluoroscopy may assist with localization in certain situations, e.g.,identifying the relevant bronchi.

Tracking using fluorescopy may be performed using a plurality ofradio-opaque markers on the endoscope. Many features of the endoscopeare naturally radio-opaque to x-rays, including the camera head, thecontrol ring and pull wires; thus, the marker location together with themetallic components of the endoscope may be used to obtain athree-dimensional transformation matrix. Once registration has happened,visual images detecting branch locations may be precisely correlated tothe three-dimensional model. In addition, the full branch length andbranch location in 3D can be measured and enhanced in the map.

In contrast to a sensor-based approach, vision-based tracking involvesusing images generated by a distally-mounted camera to determine thelocation of the endoscopic tool. For example, in bronchoscopy, featuretracking algorithms may be used to identify circular geometriescorresponding to bronchial paths and track the change of thosegeometries from image to image. By tracking the direction of thosefeatures as they move from image to image, the system may be able todetermine which branch was selected, as well as the relative rotationaland translational motion of the camera. Use of a topological map of thebronchial paths may further enhance vision-based algorithms.

In addition to feature based tracking, image processing techniques suchas optical flow may also be used to identify branches in the airwaytopology in bronchoscopy. Optical flow is the displacement of imagepixels from one image to the next in a video sequence. With respect tobronchoscopy, optical flow may be used to estimate the movement of thetip of the scope based on changes in the camera images received at thetip of the scope. Specifically, in a series of video frames, each framemay be analyzed to detect translation of the pixels from one frame tothe next. For example, if the pixels in a given frame appear totranslate to the left in the next frame, the algorithm would infer thatthe camera, and in turn the tip of the scope, moved to the right.Through comparing many frames over many iterations, movement (and thuslocation) of the scope may be determined.

Where stereoscopic image capture—as opposed to monocular imagecapture—is available, optical flow techniques may also be used tocomplement the pre-existing three-dimensional model of the anatomicregion. Using stereoscopic image capture, the depth of the pixels in thetwo-dimensional captured images may be determined to build athree-dimensional map of objects in the camera view. Extrapolating totravel within an anatomical lumen, this technique enables the system todevelop three-dimensional maps of the local surroundings around theendoscope while navigating in inside the patient's anatomy. These mapsmay be used to extend the pre-determined three-dimensional computermodels where the models either are missing data or of low quality. Inaddition to a stereoscopic camera apparatus, depth sensors or specificlighting configurations and image capture techniques—such as RGB-Dsensors or structure lighting—may need to be used.

Regardless of tracking method—either sensor-based orvision-based—tracking may be improved by using data from the endoscopictool itself. For example, in endoscopic tool 200 from FIG. 2, therelative insertion length of sheath 201 and leader 205 may be measuredfrom a known, starting position within the trachea (in the case ofbronchoscopy). Using relative insertion length and the centerlines of athree-dimensional model of the patient's bronchial tree, the system maygiving a rough estimation of the location of the working end afterdetermining whether the endoscopic tool is located in a branch and thedistance traveled down that branch.

Other control information from the endoscopic tool may also be used,such as endoscope device articulation, roll, or pitch and yaw.

Real-time imaging based on different imaging modalities would furtherenhance navigation, particularly at the operative site. Even thoughtracking may assist with rough navigation to the operative site,additional modalities may be useful when more precise handling isnecessary, such when attempting to biopsy a lesion. Imaging tools suchas fluorescence imaging, near infrared imaging, oxygen sensors,molecular biomarker images, and contrast dye imaging may help pinpointthe exact coordinates of the lesion in the computer model, and thusassist with operating a biopsy needle at the operative site. In theabsence of a precise location, the endoscopic tool may be used to biopsythe entire region of the operative site at a known depth, thus ensuringtissue from the lesion is sampled.

In some cases, the segmented CT scans, and thus the resulting computermodels, do not show branches at the periphery of the lung (in thecontext of bronchoscopy). This may be due to insufficient inflation ofthe airways during a scan, or because the size of the branches is belowthe resolution of a CT scan (typically on the order of 1 millimeter). Inpractice, the robotic system may enhance the computer model during theprocedure by noting the location and the position and orientation of theunmapped branch. In some embodiments, the topology structure may allowphysicians to mark their location and return to that same location inorder to examine the periphery branches. In some embodiments, theendoscopic camera may measure the diameter and shape of the branchesbased on the capture images, allowing those branches to be mapped basedon position and orientation.

10. Endolumenal Procedures.

FIG. 29A illustrates the distal end of an endoscopic tool within ananatomical lumen, in accordance with an embodiment of the presentinvention. In FIG. 29A, endoscopic tool 2900, comprising a shaft 2901 isshown navigating through an anatomical lumen 2902 towards an operativesite 2903. During navigation, the shaft 2901 may be unarticulated.

FIG. 29B illustrates the endoscopic tool from FIG. 29A in use at anoperative site within an anatomical lumen. Having reached the operativesite 2903, a distal leader section 2904, longitudinally aligned with theshaft 2901, may be extended from shaft 2901 in the direction marked byarrow 2905. Distal leader section 2904 may also be articulated in orderto direct tools towards operative site 2903.

FIG. 29C illustrates the endoscopic tool from FIG. 29B in use at anoperative site within an anatomical lumen. In cases where the operativesite contains a lesion for biopsy, the distal leader section 2904 mayarticulate in the direction marked by arrow 2906 to convey an aspirationneedle 2907 to target a lesion at operative site 2903. In someembodiments, distal leader section 2904 may be articulated to directbiopsy forceps to remove samples of anatomical tissues for purposes ofintraoperative evaluation. For purposes of activation of that endeffector, endoscopic tool 2900 may comprise a tendon operatively coupledto the biopsy forceps.

FIG. 30A illustrates an endoscopic tool coupled to a distal flexuresection within an anatomical lumen, in accordance with an embodiment ofthe present invention. In FIG. 30A, an endoscopic tool 3000, comprisinga shaft 3001, flexure section 3002, and forceps 3003, is shownnavigating through an anatomical lumen 3004 towards an operative site.During navigation, both the shaft 3001 and distal flexure section 3002may be unarticulated as shown in FIG. 30A. In some embodiments, theflexure section 3002 may be retracted within shaft 3001. Theconstruction, composition, capabilities, and use of flexure section 3002is disclosed in U.S. patent application Ser. No. 14/201,610, filed Mar.7, 2014, and U.S. patent application Ser. No. 14/479,095, filed Sep. 5,2014, the entire contents of which are incorporated by reference.

In some embodiments, the flexure 3002 may be longitudinally-aligned withthe shaft 3001. In some embodiments, the flexure 3002 may be deployedthrough a working channel that is off-axis (neutral axis) of shaft 3001,allowing for the flexure 3002 to operate without obscuring a cameralocated at the distal end of shaft 3001. This arrangement allows anoperator to use a camera to articulate flexure 3002 while shaft 3001remains stationary.

Similar to other embodiments, different tools, such as forceps 3003, maybe deployed through the working channel in flexure section 3002 for useat the distal end of the flexure section 3002. In other scenarios,surgical tools such as graspers, scalpels, needles, and probes may belocated at the distal end of the flexure section 3002. In endoscopictool 3000, as in other embodiments, the tool at the distal end of thebending section may be substituted intra-operatively in order to performmultiple treatments in a single procedure.

FIG. 30B illustrates an endoscopic tool from FIG. 30A with a forcepstool in use at an operative site within an anatomical lumen, inaccordance with an embodiment of the present invention. Navigation ofendoscopic tool 3000 through anatomical lumen 3004 may be guided by anynumber of the various navigational technologies discussed above. Oncethe endoscopic tool 3000 has reached its desired location at theoperative site 3006, flexure section 3002 may articulate in thedirection of arrow 3005 in order to orient forceps 3003 towardsoperative site 3006. Using forceps 3003, endoscopic tool 3000 may take abiopsy of the tissue at the operative site 3006.

FIG. 30C illustrates an endoscopic tool from FIG. 30A with a laserdevice in use at an operative site within an anatomical lumen, inaccordance with an embodiment of the present invention. Having reachedthe operative site 3006, the flexure section 3002 of endoscopic tool3000 may be articulated and a laser tool 3007 may be deployed throughthe working channel of the shaft 3001 and flexure section 3002. Oncedeployed, the laser tool 3007 may be directed to operative site 3006 toemit laser radiation 3008 for purposes of tissue ablation, drilling,cutting, piercing, debriding, cutting or accessing non-superficialtissue.

11. Command Console.

As discussed with respect to system 100 from FIG. 1, an embodiment ofthe command console allows an operator, i.e., physician, to remotelycontrol the robotic endolumenal system from an ergonomic position. Inthe preferred embodiment, the command console utilizes a user interfacethat both (i) enables the operator to control the robotic endoscopictool, and (ii) displays the navigational environment from an ergonomicposition.

FIG. 31 illustrates a command console for a robotic endolumenal system,in accordance with an embodiment of the present invention. As shown inFIG. 31, command console 3100 may comprise a base 3101, display modules,such as monitors 3102, and control modules, such as keyboard 3103 andjoystick 3104. In some embodiments, the command module functionality maybe integrated into the system cart with the mechanical arms, such assystem cart 101 from system 100 in FIG. 1.

The base 3101 may comprise of a central processing unit, a memory unit,a data bus, and associated data communication ports that are responsiblefor interpreting and processing signals, such as camera imagery andtracking sensor data, from the endoscopic tool. In other embodiments,the burden of interpretation and processing signals may be distributedbetween the associated system cart and the command console 3100. Thebase 3101 may also be responsible for interpreting and processingcommands and instructions from the operator 3105 through the controlmodules, such as 3103 and 3104.

The control modules are responsible for capturing the commands of theoperator 3105. In addition to the keyboard 3103 and joystick 3104 inFIG. 31, the control modules may comprise other control mechanisms knownin the art, including but not limited to computer mice, trackpads,trackballs, control pads, and video game controllers. In someembodiments, hand gestures and finger gestures may also be captured todeliver control signals to the system.

In some embodiments, there may be a variety of control means. Forexample, control over the endoscopic tool may be performed in either a“Velocity mode” or “Position control mode”. “Velocity mode” consists ofdirectly controlling pitch and yaw behaviors of the distal end of theendoscopic tool based on direct manual control, such as through joystick3104. For example, right and left motions on joystick 3104 may be mappedto yaw and pitch movement in the distal end of the endoscopic tool.Haptic feedback in the joystick may also be used to enhance control in“velocity mode”. For example, vibration may be sent back to the joystick3104 to communicate that the endoscopic tool cannot further articulateor roll in a certain direction. Alternatively, pop-up messages and/oraudio feedback (e.g., beeping) may also be used to communicate that theendoscopic tool has reached maximum articulation or roll.

“Position control mode” consists of identifying a location in athree-dimensional map of the patient and relying on the robotic systemto robotically steer the endoscopic tool the identified location basedon pre-determined computer models. Due to its reliance on athree-dimensional mapping of the patient, position control mode requiresaccurate mapping of the patient's anatomy.

Without using the command module 3101, the system may also be directlymanipulated by manual operators. For example, during system setup,physicians and assistants may move the mechanical arms and endoscopictools to arrange the equipment around the patient and the operatingroom. During direct manipulation, the system may rely on force feedbackand inertia control from human operators to determine the appropriateequipment orientation.

The display modules 3102 may comprise monitors, virtual reality viewingdevices, such as goggles or glasses, or other means of display visualinformation regarding the system and from the camera in the endoscopictool (if any). In some embodiments, the control modules and displaymodules may be combined, such as in a touchscreen in a tablet orcomputer device. In a combined module, the operator 3105 may be able toview visual data as well as input commands to the robotic system.

In another embodiment, display modules may display three-dimensionalimages using a stereoscopic device, such as a visor or gogglearrangement. Using three-dimensions images, the operator may view an“endo view” of the computer model, a virtual environment of the interiorof the three-dimensional computer-generated model of the patient'sanatomy to approximate the expected location of the device within thepatient. By comparing the “endo view” to the actual camera images, thephysician may be able to mentally orient himself and confirm that theendoscopic tool is in the right location within the patient. This maygive the operator a better sense of the anatomical structures around thedistal end of the endoscopic tool.

In a preferred embodiment, the display modules 3102 may simultaneouslydisplay the pre-generated three-dimensional models, the pre-determinedoptimal navigation paths through the models, and CT scans of the anatomyat the current location of the distal end of the endoscopic tool. Insome embodiments, a model of the endoscopic tool may be displayed withthe three-dimensional model of the patient's anatomy, to further clarifythe status of the procedure. For example, a lesion may have beenidentified in a CT scan where a biopsy may be necessary.

During operation, camera means and illumination means at the distal endof the endoscopic tool may generate a reference image in the displaymodules for the operator. Thus, directions in the joystick 3104 causingarticulation and rolling of the distal end of the endoscopic toolresults in an image of the anatomical features directly in front of thedistal end. Pointing the joystick 3104 up may raise the pitch of thedistal end of the endoscopic tool with the camera, while pointing thejoystick 3104 down may decrease the pitch.

The display modules 3102 may automatically display different views ofthe endoscopic tool depending on the operators' settings and theparticular procedure. For example, if desired, an overhead fluoroscopicview of the endolumenal device may be displayed during the finalnavigation step as it approached the operative region.

Elements or components shown with any embodiment herein are exemplaryfor the specific embodiment and may be used on or in combination withother embodiments disclosed herein. While the invention is susceptibleto various modifications and alternative forms, specific examplesthereof have been shown in the drawings and are herein described indetail. The invention is not limited, however, to the particular formsor methods disclosed, but to the contrary, covers all modifications,equivalents and alternatives thereof. What is claimed is:

1-20. (canceled)
 21. A robotic medical system for bronchoscopy, thesystem comprising: a moveable system cart comprising a robotic armcoupled to the moveable system cart; an endoscope removably coupled tothe robotic arm, the endoscope comprising an elongated body configuredto be inserted into and navigated through bronchial lumens of a patient,wherein a distal end of the elongated body of the endoscope isarticulable; a command console comprising a command module configured toallow an operator to remotely control the endoscope, wherein the commandmodule is configured to allow the operator to remotely articulate thedistal end of the elongated body, and wherein the command modulecomprises a trackball; a display; one or more processors configured to:track a location of the endoscope within the bronchial lumens of thepatient based on: a relative insertion length of the endoscope, and afiber optic shape sensor associated with the endoscope; and displaynavigation guidance to the operator on the display, wherein thenavigation guidance comprises a model of the lumens of the patient, anavigation path through the model, an image of the anatomy at thetracked location of the endoscope, and a model of the endoscope.
 22. Thesystem of claim 21, wherein a vision system is positioned within aworking channel of the endoscope.
 23. The system of claim 22, whereinthe vision system is removable from the working channel such thatanother tool can be inserted through the working channel.
 24. The systemof claim 23, wherein the another tool comprises a biopsy needle.
 25. Thesystem of claim 21, wherein the one or more processors are furtherconfigured to track the location of the endoscope based on orientationdata associated with the endoscope.
 26. The system of claim 25, whereinthe orientation data associated with the endoscope comprises roll,pitch, and yaw information for the endoscope.
 27. The system of claim26, wherein the orientation data is determined based on the output ofthe fiber optic shape sensor.
 28. The system of claim 26, wherein theorientation data associated with the endoscope is derived based on anoutput of an accelerometer or a gyroscope positioned on the endoscope.29. The system of claim 21, wherein the navigation guidance is based onthe tracked location of the endoscope.
 30. The system of claim 21,wherein the endoscope comprises a vision system positioned on a distalend of the elongated body, and wherein the navigation guidance providedon the display comprises an output of the vision system.
 31. The systemof claim 30, wherein a biopsy tool can be inserted into a workingchannel of the endoscope without removing the vision system.
 32. Thesystem of claim 21, further comprising an instrument device manipulatorpositioned on the robotic arm and configured to removably engage a toolbase of the endoscope to removably couple the endoscope to the roboticarm.
 33. The system of claim 21, wherein the command console comprisesthe display.
 34. The system of claim 21, further comprising aninstrument device manipulator positioned on the robotic arm, and whereinthe endoscope comprises a tool base configured to couple with theinstrument device manipulator.
 35. The system of claim 34, wherein thetool base of the endoscope comprises an electrical module fortransmitting sensor information to a corresponding module in the roboticarm.
 36. A method for performing a robotically-enabled bronchoscopyprocedure, the method comprising: navigating an endoscope to a firsttarget site within a luminal network of a patient based at least in parton the output of a navigation device positioned within a working channelof the endoscope and on the output of a fiber optic shape sensor,wherein the endoscope is robotically controlled; removing the navigationdevice from the working channel of the endoscope; inserting a biopsytool through the working channel of the endoscope; and guiding thebiopsy tool to take a biopsy at the target site based at least partiallyon an output of an external imaging device.
 37. The method of claim 36,wherein the external imaging device comprises a fluorescence imagingdevice.
 38. The method of claim 36, wherein the navigation devicecomprises an imaging device.
 39. The method of claim 36, wherein thebiopsy tool comprises a biopsy needle.
 40. The method of claim 36,further comprising: removing the biopsy tool from the working channel ofthe endoscope; and navigating the endoscope to another position based atleast in part on the output of the fiber optic shape sensor.
 41. Themethod of claim 40, further comprising: reinserting the navigationdevice into the working channel of the endoscope; and navigating theendoscope to another position based at least in part on the output ofthe navigation device.
 42. The method of claim 36, wherein navigatingthe endoscope to the first target site within the luminal network of thepatient based at least in part on the output of a navigation devicecomprises determining a location of the endoscope within the luminalnetwork of the patient based on one or more of: a relative insertionlength of the endoscope, orientation data associated with the endoscope,and an output of a fiber optic shape sensor associated with theendoscope.
 43. The method of claim 36, wherein navigating the endoscopeto the first target site within the luminal network of patientcomprises: robotically articulating a distal end of the endoscope; androbotically inserting the endoscope into the luminal network with arobotic arm.
 44. The method of claim 36, further comprising providingnavigation guidance on a display, wherein the navigation guidancecomprises: a model of the luminal network of the patient, a navigationpath through the model, an image of the luminal network, and a computermodel of the endoscope.
 45. The method of claim 36, wherein theendoscope includes a vision system, and wherein the biopsy tool orsurgical instrument is inserted into the working channel withoutremoving the vision system.